Suturing device and method

ABSTRACT

A suturing device and method allows a physician to remotely suture biological tissue. The device includes an elongate body, first and second arms operably connected to the elongated body, whereby each arm mounts an end portion of a suture, and first and second needles, each needle having a distal end and being mounted such that the distal end of the needle is movable to engage respective end portions of said suture. The suturing apparatus further includes an actuator which drives the needles to engage the suture. The suturing apparatus further includes an occluding device operably connected to the elongate body such that the occluding device may be advanced from the distal end of the elongate body to temporarily occlude the incision to be sutured.

RELATED APPLICATIONS

This application is a continuation of U.S. Utility patent applicationSer. No. 11/503,652, filed Aug. 14, 2006, which is a continuation ofSer. No. 10/435,928, filed May 12, 2003, now U.S. Pat. No. 7,090,686,which is a continuation of U.S. Utility patent application Ser. No.09/881,550, filed Jun. 14, 2001, now U.S. Pat. No. 6,562,052, which is acontinuation-in-part of International Patent Application No.PCT/US01/08050, filed Mar. 13, 2001 and published in English on Sep. 20,2001 as PCT Publication WO 01/67963, and a continuation-in-part of U.S.Utility patent application Ser. No. 09/524,211, filed Mar. 13, 2000, nowabandoned, which is a continuation-in-part of U.S. Utility patentapplication Ser. No. 09/471,866, filed Dec. 23, 1999, now U.S. Pat. No.6,245,079, which is a continuation of U.S. Utility patent applicationSer. No. 09/231,177, filed Jan. 14, 1999, now U.S. Pat. No. 6,117,144,which is a continuation-in-part of U.S. Utility patent application Ser.No. 09/036,437, filed Mar. 9, 1998, now abandoned, which is acontinuation-in-part of U.S. Utility patent application Ser. No.08/702,315, filed Aug. 23, 1996, now U.S. Pat. No. 5,860,990, whichclaims the benefit of U.S. Provisional Application No. 60/002,769, filedAug. 24, 1995. Each of the above-referenced patent applications andissued patents is incorporated in its entirety by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to suturing devices. Specifically, thepresent invention relates to suturing devices and methods for suturingbiological tissue that may not directly accessible to the physician.

2. Description of the Related Art

Physicians frequently use sutures to close cuts, punctures, incisionsand other openings in various biological tissue, such as blood vessels,of the human body.

In an arterial catheterization procedure, a relatively smallpercutaneous incision is made in the femoral or other artery. A catheteris inserted through the incision and directed along an arterial path toa target area, such as the heart, to perform one or more procedures,such as an angioplasty or angiogram. These procedures are designed to berelatively quick ‘outpatient’ procedures.

Upon completion of the catheterization procedure, the physiciantypically creates a ‘thrombus patch’ by applying direct pressure to thepatient's thigh to make the blood around the incision clot. Because thefemoral artery must not be completely blocked (occluded) by the appliedpressure, the physician commonly applies direct pressure by hand for thefirst twenty minutes after the procedure. During this time, thephysician can feel the pulse to assure the artery is not occluded.Afterwards, the physician usually turns the procedure over to anassistant who applies direct pressure using sandbags, clamps or otherdevices. A significant problem with this approach is that it isfrequently necessary to apply the pressure for an extended period oftime, such as twenty-four hours or longer.

Another problem with the thrombus patch method is that the high bloodpressure in the artery can cause the thrombus patch to rupture or burstwhile direct pressure is being applied to the thigh or after directpressure is removed. This requires the whole process to be restarted. Ifthe patch ruptures and is not restored, the patient may bleed to death.Because thrombus patches frequently burst, the patient frequently mustremain in the hospital or catheterization lab overnight for observation.Thus, these ‘out-patient’ procedures become ‘in-patient’ procedures,simply because a thrombus patch it is difficult to create. Staying inthe hospital increases patient discomfort and hospital expenses, whichare often disproportionate to the actual medical procedure performed.

Furthermore, if a thrombus patch cannot be formed, the physician mayneed to anesthetize the patient, occlude blood flow to the artery, makea large incision in the thigh to allow conventional suturing with aneedle, suture the artery with conventional means, restore blood flow tothe artery, and suture the incision in the thigh. This results inadditional discomfort and expenses for the patient.

While the above problems could potentially be avoided by suturing theblood vessel immediately following the catheterization procedure, thesize and location of the artery make suturing difficult. Specifically,the opening in the thigh is typically too small and too deep to provideenough working space for suturing the artery using conventional methods.Thus, in order to suture the vessel according to conventional methods,the opening in the thigh would have to be significantly enlarged,potentially exposing the patient to additional pain, scarring, andhealth risks.

SUMMARY OF THE INVENTION

The present invention addresses the above problems by providing asuturing device and method for suturing biological tissue, such as, forexample, an organ or blood vessel. The device is particularly wellsuited to suture an opening made in an artery, such as the femoralartery, following a catheterization procedure. The device eliminates theneed to apply pressure to a patient's thigh for an extended period oftime, and eliminates many of the complications and costs associated withthe creation of a thrombus patch.

One aspect of the present invention relates to a method of closing anopening. The method comprises inserting an elongate body into theopening wherein the elongate body is configured to deliver sutureportions through tissue adjacent the opening and has an occlusion deviceextendable from the distal end of the elongate body. The method furthercomprises positioning at least first and second suture portions throughtissue adjacent the opening. The method further comprises deploying theocclusion device in the opening to occlude the opening, applying a knotto the suture portions while the occlusion device occludes the opening,and withdrawing the occlusion device from the opening.

Another aspect of the present invention relates to a method of closingan opening. The method comprises placing at least two suture portionsthrough tissue adjacent the opening, delivering an occlusion device to alocation adjacent the opening and positioning the occlusion deviceagainst the opening to occlude the opening. The method further comprisesapplying a knot to the two suture portions while the occlusion deviceoccludes the opening and removing the occlusion device from the opening.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates one embodiment of the present invention in anexemplary use environment.

FIG. 1B illustrates a cross-sectional view of the device in FIG. 1A inan exemplary use environment, such as a patient's thigh.

FIG. 1C illustrates another embodiment of the present invention in theexemplary use environment of FIG. 1A.

FIG. 1D illustrates a cross-sectional view of the device in FIG. 1C inan exemplary use environment, such as a human thigh.

FIG. 2 is a partial cross-sectional view of the suturing device depictedin FIG. 1A having a suture catch assembly and a suture introducerhousing.

FIG. 3 is a bifurcated perspective view of the suture introducer housingof FIG. 2.

FIG. 4A is a partially schematic perspective view of the suture clasparms of FIG. 2.

FIG. 4B is a partial cross-sectional view of one configuration of sutureclasp arms.

FIG. 4C is a partial cross-sectional view of another configuration ofsuture clasp arms.

FIG. 4D is a partial cross-sectional view of yet another configurationof suture clasp arms.

FIG. 4E is a partial cross-sectional view of yet another configurationof suture clasp arms.

FIG. 5 is an elevational view of one configuration of a suture clasparm.

FIG. 6 is an elevational view of another configuration of a suture clasparm.

FIG. 7 is an enlarged elevational view of one configuration of a sutureclasp.

FIG. 8 is an enlarged elevational view of a suture having bands crimpedthereon.

FIG. 9 is an enlarged elevational view of another configuration of asuture clasp.

FIG. 10 is an elevational view of the suture clasp of FIG. 9illustrating the action of a suture and the suture clasp as the sutureis being removed from the suture clasp.

FIG. 11A is a cross-sectional top view of one configuration of a sutureintroducer housing, suture clasp arms, a suture, and a triangularspreader.

FIG. 11B is a cross-sectional side view of the suture introducer housingand triangular spreader of FIG. 11A.

FIGS. 12 and 13 are partial cross-sectional views of anotherconfiguration of a spreader for deploying the suture clasp arms.

FIG. 14 is a partial cross-sectional view of an alternate configurationof the device for deploying the suture clasp arms.

FIG. 15 is a partial cross-sectional view of an alternate configurationof suture clasp arms.

FIG. 16 is a partial cross-sectional view of the device of FIG. 15illustrating the suture clasp arms in a deployed position.

FIG. 17 is a bifurcated perspective view of the suture catch assembly ofFIG. 2.

FIG. 18 is a partial cross-sectional view of an alternate configurationof the suture catches and the suture clasp arms.

FIG. 19 is a schematic perspective view of a needle tip and oneconfiguration of a suture catch.

FIG. 20 is a cross-sectional view of the suture catch of FIG. 19 takenalong line 19-19 illustrating the position of a suture fitting capturedby the suture catch.

FIG. 21 is a cross-sectional top view of the suture catch of FIG. 19taken along line 20-20.

FIG. 22 is a schematic illustration of another configuration of a suturefitting.

FIG. 23 is a side view of a suture clasp arm used to hold the suturefittings of FIGS. 20 and 22.

FIG. 24 is a rear elevational view of a needle tip with an alternateconfiguration of the suture catch.

FIG. 25 is a cross-sectional view of the needle tip of FIG. 24 takenalong line 24-24 of FIG. 24.

FIG. 26 is a partial cross-sectional side view of an alternateconfiguration of a suture clasp arm to hold a suture fitting.

FIG. 27 is an end view of the suture clasp arm of FIG. 26.

FIG. 28 is a perspective view of a three-sector arm actuator assemblywith a catch in a distal position.

FIG. 29 is a perspective view of a button of the assembly of FIG. 28.

FIG. 30 is a perspective view of a guide of the assembly of FIG. 28.

FIG. 31 is a perspective view of the catch of the assembly of FIG. 28.

FIG. 32 is a perspective view of the assembly of FIG. 28 with the catchin a proximal position.

FIG. 33 is a schematic partial cross-sectional view of the assembly ofFIG. 28 with the catch in a distal position.

FIG. 34 is a partial cross-sectional view of the suture introducerhousing of FIG. 2 with the introducer over the housing.

FIG. 35 is a partial cross-sectional view of the suture introducerhousing of FIG. 2 with the suture clasp arms deployed.

FIG. 36 is a partial cross-sectional view of the suture introducerhousing and suture catch assembly of FIG. 2 illustrating the operationof the suture catch assembly.

FIG. 37 is a partial cross-sectional view of the suture introducerhousing and the suture catch assembly of FIG. 2.

FIG. 38 is a schematic view of a vessel illustrating the location of thesuture.

FIG. 39 is a schematic cross-sectional view of the vessel of FIG. 38taken along line 40-40.

FIG. 40 is a partial schematic cross-sectional view of one configurationof the suturing device having a detachable arm deployment handle.

FIG. 41 is a cross-sectional view of the embodiment depicted in FIG. 1Cwith the distal end inserted through an arterial wall.

FIG. 42 is a cross-sectional view of the device of FIG. 41 with thesuture clasp member partially deployed.

FIG. 43A is a perspective view of a suture clasp member, an actuator anda hollow elongated body of FIG. 41.

FIG. 43B is an exploded view of the suture clasp member, pivot pin andactuator of FIG. 42.

FIG. 43C is a perspective view of a two-piece suture clasp member.

FIG. 43D is a cross-sectional view of the two-piece suture clasp memberof FIG. 43C and a spreader within the suture introducer head of FIG. 41.

FIG. 44 is a perspective view of the suture introducer head and sutureclasp member of FIG. 41.

FIG. 45 is perspective view of the device of FIG. 44 with the sutureclasp member partially deployed.

FIG. 46 is a rear perspective view of the device of FIG. 44.

FIG. 47 is cross-sectional view of the device of FIG. 41 with the sutureclasp member fully deployed.

FIG. 48 is a cross-sectional view of another embodiment of the presentinvention.

FIG. 49 is a cross-sectional view of one embodiment of a handle capableof being attached to the proximal end of the device of FIG. 41, thedevice of FIG. 48 or the device of FIG. 52A.

FIG. 50 is a perspective view of the handle of FIG. 49.

FIG. 51 is a cross-sectional view of another embodiment of a handlecapable of being attached to the proximal end of the device of FIG. 41,the device of FIG. 48 or the device of FIG. 52A.

FIG. 52A is a perspective view of the suture introducer head and thehollow elongated body of FIG. 41 with another embodiment of the sutureclasp arms.

FIG. 52B is a cross-sectional view of the device of FIG. 52A.

FIG. 53A-53B are perspective views of one configuration of the sutureclasp member of FIG. 52A.

FIG. 54 is a perspective view of the device of FIG. 52A with the sutureclasp member partially deployed.

FIG. 55 is a perspective view of the device of FIG. 52A with the sutureclasp member fully deployed.

FIG. 56 is a perspective view of the device of FIG. 52A with the sutureclasp member fully deployed and needles engaging the suture claspmember.

FIG. 57 is a perspective view of the handle of FIG. 49.

FIGS. 58-59 are perspective views of a four-arm suture clasp member usedwith the device of FIG. 1C-1D.

FIG. 60 is an exploded view of another embodiment of a handle capable ofbeing attached to the proximal end of the device of FIG. 41, the deviceof FIG. 48 or the device of FIG. 52A.

FIG. 61 is a perspective view of the handle of FIG. 60.

FIG. 62 is a perspective view of another configuration of the sutureintroducer head and the hollow elongated body of FIG. 52A with sixsuture clasp arms.

FIG. 63 is a perspective view of the device of FIG. 62 with the sutureclasp arms fully deployed.

FIG. 64 is a perspective view from the distal end of the device of thesix suture clasp arms of FIG. 62.

FIG. 65 is a perspective view of the device of FIG. 62 with the sutureclasp arms fully deployed and a set of needles engaging the suture clasparms.

FIG. 66 is a perspective view from the distal end of another suturedevice configuration of the present invention with four suture clasparms.

FIG. 67 is a perspective view of the suture device of FIG. 66 with thesuture clasp arms fully retracted.

FIG. 68 is a perspective view of the suture device of FIG. 66 with thesuture clasp arms partially deployed.

FIG. 69 is a perspective view of the suture device of FIG. 66 with thesuture clasp arms fully deployed and a set of needles.

FIGS. 70-71 illustrate a removable sheath that may be used with thesuture devices shown in FIGS. 1A-69.

FIGS. 72-73 illustrate occlusion devices that may be used with thesuture devices shown in FIGS. 1A-69.

FIG. 74A is an exploded cross-sectional view of another embodiment of ahandle capable of being attached to the proximal end of the device ofFIG. 41, the device of FIG. 48 or the device of FIG. 52A.

FIG. 74B is an exploded cross-sectional view of another embodiment of ahandle adapted to separately actuate the first and second needles.

FIGS. 75A and 75B are exploded, cross-sectional, perspective views ofthe handle of FIG. 74A.

FIG. 76A is an exploded, cross-sectional, perspective view of the handleof FIG. 74B.

FIGS. 76B-D schematically illustrate various embodiments of the needledrivers adapted to separately actuate the first and second needles.

FIG. 77 illustrates the suture device of FIG. 56 adapted to move a firstneedle distally to engage a first suture clasp arm before moving asecond needle distally to engage a second arm.

FIG. 78 illustrates the suture device of FIG. 77 with the second needlemoving distally.

FIG. 79 illustrates the suture device of FIG. 77 with the first needlepiercing a first biological tissue portion and engaging the first sutureclasp arm.

FIG. 80 illustrates the suture device of FIG. 77 with the second needlepiercing a second biological tissue portion and engaging the secondsuture clasp arm.

FIG. 81 illustrates the first and second biological tissue portionsbeing drawn together by a suture inserted by the suture device of FIG.77.

FIG. 82A illustrates the suture device of FIG. 77 with a patch deployedfrom the elongated body.

FIG. 82B illustrates the patch of FIG. 82A occluding the suture site.

FIG. 83A illustrates a patch connected to the ends of the suture beforedistally sliding the patch toward the suture site.

FIG. 83B illustrates the patch of 83A occluding the suture site with aknot securely holding the patch in place.

FIG. 84 illustrates a patch with two pairs of sutures through the patch.

FIG. 85 illustrates a suture device with a steerable portion and a firstneedle piercing a first biological tissue portion.

FIG. 86 illustrates the suture device of FIG. 85 with a second needlepiercing a second biological tissue portion.

FIGS. 87-102 illustrate methods of forming suture ends of a suture whichmay be used with the suture devices described herein, in which:

FIG. 87 shows a strand of material being brought into a stream of hotgas;

FIG. 88 shows a distal end of the strand being thermally deformed toform a deformed region such as a globule;

FIGS. 89 and 90 show a die for flattening the deformed region;

FIG. 91 shows the strand after the deformed region has been flattened;

FIG. 92 shows the strand after excess material has been cut away fromthe deformed region;

FIG. 93 shows the strand after an eyelet has been formed in theflattened, deformed region;

FIG. 94 shows a suture in which eyelet portions have been formed at bothends of the suture;

FIG. 95 shows the deformed region placed between two blocks havingrecessed portions therein;

FIG. 96 shows the deformed region after it has been squeezed between theblocks to form a cylindrically shaped member;

FIG. 97 shows a hole being formed in the deformed region with ahypotube;

FIG. 98 shows the formed hole in the deformed region, resulting in acup-like member at the end of the strand;

FIGS. 99 and 100 show views of a one embodiment of a surgical needle tobe used with the cup-like member of FIG. 98;

FIG. 101 shows the surgical needle having entered the cup-like memberand secured to it; and

FIG. 102 shows an embodiment having cup-like members at both ends of thesuture.

FIG. 103A shows a side view of the distal portion of the device with oneend portion of the suture captured by a needle extended through thetissue structure and a second end portion of the suture looped around asecond tissue structure.

FIG. 103B shows a side view corresponding to FIG. 103A once the endportions of the suture have been tied together and tightened.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides a suturing device for suturing biologicaltissue. The suturing device may be used to seal a blood vessel followingan interventional catheterization procedure, such as an angiogram. FIGS.1A-1B illustrate one embodiment of the present invention in an exemplaryuse environment. As depicted by FIGS. 1A-1B, the physician makes aninitial incision 20 in the upper thigh 12 of a patient 2. The physicianthen inserts a needle (not shown) into the incision 20. When bloodbleeds back from the insertion, the physician knows the needle haspierced the femoral artery 16. The physician then inserts a guidewire(not shown) through the needle and into the artery. The physician maytake the needle out and insert a plastic needle (not shown) over theguidewire once the guidewire is in place. The guidewire may then betaken out.

With this needle in place, the physician can insert a catheter sheathintroducer (CSI) 6, also called an introducer sheath. This introducersheath 6 is typically a single lumen catheter with a valve on itsproximal end. The valve is used to prevent extraneous bleed back or tointroduce medication into the patient's body. The vessel incision 26provides access for medical instruments and probes inside the arterialvessel 16. Instruments may be inserted into artery 16 via the introducersheath 6 to perform various procedures in the body.

In FIG. 1A, the suture assembly 4 consists of the suture catch assembly36 (described below), the suture introducer housing 24, and theintroducer sheath 6. FIG. 1B illustrates a cross-sectional view of thedevice depicted in FIG. 1A in an exemplary use environment, such as apatient's thigh. After the medical procedure described above, thephysician withdraws the CSI 6 and inserts the suture catch assembly 36and the suture introducer housing 24 through the first incision 20. Thesuture catch assembly 36 and suture introducer housing 24 pass throughthe flesh 14 of the patient's thigh 12 and through the second incision26 into the femoral artery 16. In another method, the physician mayfirst insert the suture introducer housing 24, remove the CSI 6, andthen insert the suture catch assembly 36.

FIGS. 1C and 1D illustrate another embodiment of the present inventionin the exemplary use environment of FIG. 1A. Unlike the deviceillustrated in FIGS. 1A-1B, the device illustrated in FIGS. 1C-1D doesnot require the removal of the CSI 6 in order for the device to deploy asuture. Several embodiments of the device shown in FIGS. 1A and 1B willnow be described with reference to FIGS. 2-40. The device depicted inFIGS. 1C-1D will thereafter be described in further detail below withreference to FIGS. 41-50.

Embodiments of FIGS. 1A-1B and 2-40

FIG. 2 shows one embodiment of the suturing device for suturing vesselwalls and other biological tissue. Preferably, the device is for use insuturing arterial vessel walls 22. However, the device could be used tosuture other tissue such as a patent ductus arteriosus, a patent foramenovale, a heart defect, a puncture wound, and the like. The suturingdevice comprises a suture introducer housing 24 for insertion into anopening 26 in the arterial wall 22.

Suture clasp arms 28, 30 are deployably housed in the housing 24 duringinsertion. After insertion into the vessel 16, the arms 28, 30 aredeployed to the position shown in FIG. 2. When deployed, the sutureclasp arms 28, 30 extend outside the circumference of the sutureintroducer housing 24. In certain embodiments, the arms 28, 30 extendfrom the housing in a symmetric configuration, in which each arm 28, 30has the same angle with respect to the axis of the housing 24.Alternatively, in other embodiments, each arm 28, 30 can extend from thehousing in an asymmetric configuration, in which each arm 28, has adifferent angle with respect to the axis of the housing 24. Furthermore,in certain embodiments, the arms 28, 30 are spaced equidistantly aroundthe circumference of the housing 24. Equidistant spacing as used hereinmeans that the azimuthal angle between the two arms 28, 30 is 180degrees, where the azimuthal angle between the two arms 28, is the anglebetween the plane defined by the axis of the housing 24 and the firstarm 28 and the plane defined by the axis of the housing 24 and thesecond arm 30. Alternatively, in still other embodiments, the arms 28,30 are spaced non-equidistantly around the circumference of the housing24 (e.g., the azimuthal angle between the two arms 28, 30 is 90degrees).

Each arm has at least one suture clasp 32, schematically illustrated,for clasping a suture 40. A penetrating mechanism, generally designated34, is provided for penetrating the vessel wall 22. The penetratingmechanism 34 is provided on either the suture introducer housing 24 oron a suture catch assembly, generally designated 36. When, as shown inFIG. 2, the penetrating mechanism 34 is part of the suture catchassembly 36, the penetrating mechanism 34 also comprises suture catches38 for catching the suture 40 and dislodging it from the suture clasps32. The suture catch assembly 36 operates to pull the suture 40 held bythe suture catches 38 through the vessel wall 22. After the ends of thesuture 40 are pulled outside the vessel wall 22, the introducer housing24 can be removed and the suture 40 tied to close the vessel opening 26.

FIG. 3 shows one configuration where the suture introducer housing 24 isa generally cylindrical and thin walled hypo tube. The term “hypo tube”is used to describe a hollow elongated cylindrical member with a thinwall such that the inner diameter and outer diameter vary by arelatively small amount in the range of few thousandths of an inch totens of thousandths of an inch. The outer surface 42 of the housing 24comprises a key way groove 44 (exaggerated for clarity) to align thehousing 24 with a key 46 (FIG. 17) on the inner surface 48 of the suturecatch assembly 36. An arm actuation assembly 170, to be described below,for deploying the suture clasp arms 28, 30 protrudes from the proximalend of the housing 24, and an actuating wire or rod 50 extends from theactuation assembly 170 through the housing 24 to the suture clasp arms28, 30.

FIG. 2 shows one configuration where the suture clasp arms 28, 30 areattached to the distal end 54 of the actuating rod 50. In thisconfiguration, the arms 28, 30 are pivotally attached to the actuatingrod 50 and pivot around pivot shaft 56. The suture 40 is held inside thehousing 24 and is positioned underneath the spreader 102, so that it canbe removed from the entire housing 24. The arms 28, 30, which are shownin more detail in FIGS. 4A and 4B, terminate with the suture clasps 32(schematically illustrated). Each arm 28, 30 has an elongated body 58which attaches to the pivot shaft 56 at one end and to the suture clasp32 at the other. The length of the body 58 controls how far beyond thecircumference of the suture introducer housing 24 the arms 28, 30 extendwhen they are deployed by the actuating rod 50.

As illustrated in FIG. 4B, the proximal sides of the suture clasp arms28, 30 near the slots 76 which receives the suture 40 are substantiallyparallel to the vessel wall 22 when the arms 28, 30 are deployed withinthe vessel 16. The proximal sides of the suture clasp arms 28, 30 canthen provide mechanical support for the vessel wall 22 in the region ofthe opening 26. In an alternative configuration, as illustrated in FIG.4C, the proximal sides of the suture clasp arms 28, 30 have an upwardcurvature near the slots 76, thereby defining a proximally projectingportion on the proximal side of each of the arms 28, 30. In thisconfiguration, the proximal side of the arms 28, 30 provide mechanicalsupport for the vessel wall 22 while the proximally projecting portionsprovide an improved purchase on the vessel wall 22. This configurationthen reduces the probability of slippage of the arms 28, 30 relative tothe vessel wall 22 when the arms 28, 30 are deployed within the vessel16. Other configurations can have multiple proximally projectingportions on each arm 28, 30, or can have proximally projecting portionswhich are protuberances on the proximal sides of arms 28, 30 withoutupward curvature. These proximally projecting portions can have variouscross-sectional shapes, such as triangular or trapezoidal. Still otherembodiments can have relatively small proximally projecting portionswhich have areas smaller than the area of the proximal side of the arms28, 30. In addition, other embodiments have proximally projectingportions which are in proximity to the portion of the arms 28, 30 whichmount the end portions of the suture, such as the slots 76 illustratedin FIG. 4C. The proximally projecting portions can also be located inproximity to the ends of the arms 28, 30 away from the pivot shaft 56.

Similarly, other configurations of suture clasp arms 28, 30 can haveproximally projecting portions on each of the arms 28, 30. FIG. 4Dillustrates such proximally projecting portions on arms 28, 30 such asthose described below in conjunction with FIGS. 43-47, and FIG. 4Eillustrates such proximally projecting portions on arms 28, such asthose described below in conjunction with FIGS. 52-56.

FIG. 5 shows an alternate configuration of the arms 28, 30. In FIG. 5,the arms 28, 30 are Y-shaped with an offset body 64, and there is asuture clasp at each tip 60, 62 of the Y-shaped arm. The body 64 is offcenter from the tips 66, 68, so that a complimentary arm can pivot onthe same pivot shaft 56 without interference. Thus, the Y-shape of thearms allows them to pivot beside each other outwardly from and inwardlyto their undeployed position without interference from the other arm.The Y-shape of the arm also provides an open area or suture catchreceiving area 80 into which the suture catch 30 fits to catch thesuture 40. Other arm shapes such as the h-shaped arm shown in FIG. 6 mayprovide the same or additional benefits. The h-shaped arm has a body 70with an aperture 71 for attachment to a pivot shaft 56 and each tip 72,74 of the arm is provided with a suture clasp. The body of the h-shapedarm is positioned all the way to the side of the arm and functionssimilarly to the Y-shaped arm. The configuration of the suture clasp armshown in FIG. 6 also has a suture catch receiving area 80A.

FIGS. 7 and 8 illustrate one configuration of the suture clasp 32, whichcomprises a key hole shaped slot 76 which widens toward the end of thetip to receive the suture 40. As illustrated in FIG. 4, a loop 78 istied in each end of the suture 40. The loop 78 is sized to fit tightlybetween the suture clasps 32 on each arm 28, 30. The key hole shapedslot 76 is elongated and narrows away from the end of the tip 60 to aneck 82 having a width W. The end 84 of the slot 76 is circular with adiameter greater than the neck width W. The diameter of the circular end84 of the slot 76 is sized to receive either the outer diameter of asuture 40, shown in FIG. 8, or the outer diameter of cylindrical bands86 which are crimped onto the suture 40. The suture 40 or the bands 86have an outer diameter approximately the same size as the diameter ofthe end of the slot 76 but smaller than the neck width W. Because thediameter of the bands 86 (or suture 40) is smaller than the width of theneck 83, the bands 86 snap into the end of the slot 76 and are securelyheld therein until removed by the suture catch 38. In an alternateconfiguration (FIG. 14), it is desirable for the slots 76 to openupwardly when they are in the deployed position, so that the suture 40is pulled straight up out of the slots 76.

FIG. 9 shows another configuration of the suture clasps 32. In thisconfiguration, the arm 28, 30 comprises a shaft 88 extending to a plateor bar 90. A resilient element 92, such as a spring, is attached at eachend of the bar 90, and tips 94 are attached to the end of each resilientmember 92. The tips 94 have slots as previously described and shown byFIG. 7. The suture 40 has beads 96 fixed thereto or knots tied therein.The beads are spaced apart by a distance just less than the distancebetween the outer edges 98 of the tips 94. With this distance betweenthe beads 96, the tips 94 must be slightly bent toward each otherthereby loading the resilient members 92 to receive the suture 40. Whenthe tips 94 are pulled inwardly and the resilient members 92 loaded, thesuture 40 is held in place by the force from the resilient members 92.Therefore, the suture 40 is held in tension between the tips 94.

When the suture catch 38 is guided through the suture catch receivingarea 100, the resilient members 92 are further deformed as the suture 40is forced to make an arc to receive the suture catch 38 as illustratedin FIG. 10. The resilient members 92 then bend in the direction that thesuture catch 38 is retracted, so that the suture 40 slides smoothly outof the clasp 32. If desired, the outer edges 98 of the tips may beindented 99 to receive and more securely hold the beads 96 or knots onthe suture 40.

FIG. 14 illustrates an alternate configuration of the suture clasp slot.The slot 127 opens upwardly toward the penetrating mechanism instead oftransverse to the penetrating mechanism as in the previousconfiguration.

In FIG. 2, the suture clasp arms 28, 30 are deployed when the actuationrod 50 forces the arms 28, 30 downward to a triangular spreader 102.FIG. 11A is a cross-sectional top view of one configuration of thesuture introducer housing 24, the clasp arms 28, 30, the suture 40, anda triangular spreader 102. FIG. 11A shows the triangular spreader 102extending across a diameter line of the suture introducer housing 24.The spreader 102 may be shaped in alternative forms other than atriangle.

FIG. 11B is a side view of one configuration of the suture introducerhousing 24, the triangular spreader 102 and the direction of the clasparms 28, 30 as they extend downward into the blood vessel 16. One vertex104 of the triangular spreader 102 is positioned centrally in thehousing 24 and extends upwardly. The triangle is preferably isosceleswith respect to the upward extending vertex 104, so that the arms 28, 30spread uniformly when they engage the spreader 102 and pivot about thepivot shaft 56. Each arm 28, 30 ultimately extends the same distancebeyond the circumference of the housing 24. The surfaces of the spreader102 and arms 28, 30 which engage to deploy the arms are preferablysmooth, so that the deployment of the arms 28, 30 is smooth.

Another configuration for deploying the suture clasp arms is shown inFIGS. 12 and 13. The arms 106 are pivotally attached to the actuatingrod 50 with a pivot shaft 109, and a circular spreader bar 108 or campin extending across a diameter line of the housing 110. When theactuating rod 50 forces the suture clasp arms 106 to engage the circularspreader 108, they are forced into the deployed position of FIG. 13. Toobtain smooth deployment of the arms 106, the bottom surface 107 of thearms 106 forms a curved camming surface for engaging the circularspreader 108. The housing 110 has two slit shaped openings 112 evenlyspaced around the circumference of the housing 110 through which thearms 106 extend into the deployed position. The end of the openings 112also forms a stop 113 to prevent the arms 106 from moving past thedeployed position. With the openings 112 in the housing 110, the shapeof the arms 106 is simplified. Because the arms 106 do not have to curvedown out of the housing 110, the arms 106 are straighter than in theprevious configurations.

An alternative means for deploying the clasp arms is illustrated in FIG.14. Each clasp arm comprises an upper lever arm 114 pivotally attachedat one end to the actuating rod 50 with a pivot shaft 116 and a lowerpivot arm 118 pivotally attached to the other end of the upper lever arm114. The lower pivot arm 118 rotates around a pivot shaft spreader 120which is attached to the housing 122 and extends across a diameter lineof the housing 122. When the actuating rod 50 is forced distally fartherdown the housing 122, the lower pivot arms 118 are forced to pivotaround the pivot shaft spreader 120, and the arms 118 are deployed tothe position shown in solid lines. As the lower pivot arm 118 rotates,the upper lever arm 114 rotates relative to the pivot shaft 116, and thejunction 124 between the upper and lower arms is translated downward(distally) and outwardly toward the circumference of the housing. Whenthe actuating rod 50 is retracted from the housing, the junction ismoved upward and centrally in the housing 122, and the lower pivot arm118 is rotated to the retracted position shown in partial dashed lines.

The housing 122, similar to the configuration of FIG. 13, has slitopenings 126. The openings 126 extend a greater distance along thelength of the housing 122 than in FIG. 13 to allow room for the lowerpivot arm 118 to exit the housing 122 and provide sufficient room forthe junction 124 to move outwardly.

A stop 129 attached to the upper lever arm 114 is placed between theupper lever arm 114 and the lower pivot arm 118 to prevent the arms frommoving past the deployed position. Alternatively, the stop 129 can beinherent in the lower pivot arm 118 and upper lever arm 114. This wouldinclude a notch on the side of one of the arms which the other arm wouldcontact to limit the movement of the arms.

FIG. 14 illustrates the use of a sealing member 52 inside the sutureintroducer housing 24. The sealing member 52 prevents blood flow backthrough the housing 122.

Still another configuration of the clasp arm deployment mechanism isillustrated in FIGS. 15 and 16. In this configuration, a singleresilient arm 128 is attached to the actuating rod 50. The resilient arm128 is predisposed in a deployed configuration shown in FIG. 16. Whenthe arm 128 is retracted into the housing 24, the prongs 130 of the arm128 are elastically deformed inwardly. When the arm 128 is moved out ofthe housing 24 by the actuating rod 50, the prongs 130 expand to thepredisposed deployed position. This configuration is easily adaptable tohaving four prongs 130 spaced at ninety degrees. Thus, any configurationand number of prongs can be incorporated into the device depending onthe specific needs of the application.

FIGS. 2 and 17 illustrate a preferred configuration of the suture catchassembly 36 with a generally cylindrical outer tube 132, which, asdescribed above, includes a key 46 to mate with the key way groove 44 ofthe suture introducer housing 24. The inner diameter of the tube 132 issized to fit over the outer diameter of the suture introducer housing 24without any interference. This fit does not need to be tight because thesuture catch assembly 36 is not inserted into the opening 26 of thevessel 16. Therefore, there is no need to prevent the flow of bloodbetween the suture housing 24 and the suture catch assembly 36. Also,the fit between the suture catch assembly 36 and the suture introducerhousing 24 does need to be close enough to assure that the suture catch38 is properly aligned with respect to the suture clasps 32. Properalignment is accomplished by a close fit between the key 46 and the keyway groove 44.

The catch assembly 36 comprises a plurality of, preferably two,apertures 134 for slidably receiving respective needles 136 or otherpenetration members. The apertures 134 extend through the length of thetube 132 and may be equally spaced around the circumference of the tube132 in one configuration of the device.

The blunt ends 138 of the needles 136 are connected to an activationring 140, and springs 142 are interposed between the activation ring andthe tube 132. The springs 142 hold the needles in a retracted positionso that the needle points are within the tube 132. With the needles 136biased in a retracted position by the springs, the suture catch assembly36 can be handled without the chance of inflicting an unintentionalpuncture wound.

At least one stop 144 is fixed on the inner surface 48 of the tube 132and engages the top 146 of the suture housing 24 to fix the relativeposition between the suture housing 24 and the catch assembly 36.Because the spring 142 can only be compressed a certain distance, thedepth of entry of the needles 136 into the vessel 16 is controlled toprevent puncturing the opposite side of the vessel 16. Furthermore, thefixed relative position between the suture housing 24 and catch assembly36 assures that the needles 136 pass far enough into the suture catchreceiving area 80 to catch the suture 40.

Near the end of each needle 136 is the suture catch 38. The suture catch38 is an aperture extending to the outer edge on one side of the needle136. The aperture is slot shaped and angled upwardly toward the proximalend of the device. While the needles are being pulled from the vessel16, the suture 40 is pulled to the bottom of the suture catch 38 whereit cannot come loose.

FIG. 18 shows an alternate configuration of a penetrating mechanism,generally designated 150, with the suture introducer housing 152. Thepenetrating mechanism comprises needle points 154 press fit onto arms156. The end of the arms 156 opposite the needle points 154 are fixed tothe actuating rod 50. The arms 156 are made of a resilient materialexhibiting shape memory such as NITENOL, and the arms 156 are at rest ina deployed position shown in dashed lines. When the arms 156 are withinthe suture housing 152, they are deformed to fit within the housing 152.When the actuating rod 50 pushes the needle points 154 beyond the suturehousing, the arms 156 return to their at-rest position with the needlepoints 154 beyond the circumference of the housing 152. The suture 40 isattached to the needle points 154. The needle points 154 are then pulledupward by the actuating rod 50 toward the vessel wall 22, therebypenetrating the vessel wall 22 from within the vessel 16.

The suture catch 158 has a V-shaped notch 160 with rounded tips 162.There is a slit 164 extending up from the vertex of the notch 160. Therounded tips 162 prevent the suture catch 158 from inadvertentlypuncturing the vessel wall 22. The needle points 154 fit into thenotches 160 and cause the notches 160 to open farther along the slits164. After the needle points 154 are inside a cavity 166 within thesuture catch 158, the notch 160 collapses to its original shape andtraps the needle points 154 inside. The suture catch 158 is then pulledproximally until the press fit between the needle points 154 and thearms 156 is overcome, and the needle points 154 are separated from thearms 156. The actuation rod 50 is then moved proximally to pull the arms156 both into the housing 152.

For this configuration, an alignment mechanism can be provided such asthe key way described above. But in the configuration shown, the notchis circumferential. Thus, no alignment mechanism is needed, and anynumber of arms 156 extending from the actuating rod can be provided.

The suture catch 158 can be positioned over an introducer 168 ifdesired. If the proximal end of the introducer 168 is too large for thesuture catch 158 to fit over, the suture catch 158 could be made of aflexible material with a longitudinal slit over its entire lengthallowing it to be expanded to fit around the diameter of the introducer168. The arms 156 would be modified so that the needle points 154 extendbeyond the circumference of the introducer 168.

FIGS. 19 through 23 illustrate an alternate configuration of the suturecatch and suture clasp. A needle 400 is provided with a slotted opening402 having a peg 404 extending from the top of the opening 402 through aportion thereof. The peg 404 has a narrow and rounded front peg surface406 with an identical radial location on the needle 400 as the outersurface of the needle 400. The back peg surface 408 of the needle 400 isrelatively wide, rounded, and located toward the radial center of theneedle 400. The peg sides 410 are flat and angled relative to the walls412 of the slotted opening 402. The slotted opening 402 receives suturefitting 414 having a shaft 416 connected, preferably by crimping, to thesuture 40 and an enlarged termination 418 which is preferably spherical.

The alternate suture fitting 420 of FIG. 22 has a half sphericaltermination 422 with rounded edges. The half spherical termination 422does not protrude beyond the diameter of the needle 400. This halfspherical termination 422 reduces the trauma to the vessel wall 22 whenthe needle 400 is retracted. The shaft in either configuration has alength short enough not to protrude from the diameter of the needle 400when the suture fitting is held by the needle 400. This also reducestrauma to the vessel wall 22 during retraction.

The suture fitting 414 is held by a modified suture clasp arm 424 havingan aperture 426 to receive the shaft 416 of the suture fitting 414. Thewall 428 of the aperture is slowly tapered so that the diameterdecreases as the aperture 426 moves inwardly in the arm 424. Thisfrustoconical shape provides a secure press fit with the suture fittingshaft 416. Other aperture shapes are possible so long as the press fitis secure and is of a force which can be overcome by the retraction ofthe arm 424. The shaft 416 of the suture fittings can also be tapered tobetter mate with the aperture 426.

When the suture clasp arm 424 is deployed, the termination 418, 422engages the peg 404 forcing it to one side allowing the termination 418,422 to slide against the peg 404 until the termination 418, 422 is pastthe peg 404. When the termination 418, 422 slides past the peg 404, thepeg 404 snaps toward its at rest central position thereby capturing thetermination 418, 422 and hence the suture 40. When the suture clasp arm424 is retracted, the press fit is overcome and the suture fitting 414is pulled from the arm 424. When the peg 404 snaps back into its centralposition, it tends to pull the suture fitting 414 away from the sutureclasp arm 424. This can be utilized to help overcome the press fit. Withthe suture filling securely held, the needles are retracted, the suturefittings 414 cut from the suture 40, and the suture 40 tied.

FIGS. 24 and 25 illustrate another configuration of the suture catch. Aneedle 450 is provided with a slot shaped opening 451 with a U-shapedraised portion 452 in the lower front of the slot 451. The opening 451also defines a suture fitting receiving area 454 at the top of theopening 451 for receiving a suture fitting 456 and a suture fittingcatch area 458 in the lower back of the slot adjoining the raisedportion 452. The suture fitting 456 has a spherical tip 459, and anarcuate neck 460 which tapers down to a cylindrical shaft 462. Thespherical tip 459 is sized to fit through the suture fitting receivingarea 454 but not through the U-shaped raised potion 452. Thus, theraised portion 452 holds the suture fitting 456 in the suture fittingcatch area 458. The raised portion 452 angles toward the back of theneedle 450, so that it becomes larger as it extends farther down theneedle 450.

FIGS. 26 and 27 show another configuration of the suture clasp arms 464,which comprises an upwardly facing key hole shaped opening 466 forholding the suture fitting 456. The opening 466 faces upwardly, that isin the direction of needle retraction, to aid in the removal of thesuture fitting 456 from the suture clasp arm 464.

In operation, the suture catch is activated to penetrate the tissue tobe sutured. The suture clasp arms 464 are deployed directing the suturefitting 456 into the suture fitting receiving area 454. As the suturecatch needle 450 is retracted, the neck 460 of the suture fitting 456 isengaged by the raised portion 452, and the angled surface of the raisedportion 452 pulls the suture fitting 456 farther and farther toward theback of the needle. Thus, the suture fitting 456 is being pulled out ofthe suture clasp arm 464 as the needle 450 is retracted. If the suturefitting 456 is not completely removed from the suture clasp arm 464 whenit contacts the bottom of the opening 451, it is snapped upwardly pass aneck 468 of the key hole opening 466 and out of the suture clasp arm464.

The control of the distal and proximal translation of the actuating rod50 is preferably performed by the three sector, arm actuator assembly,generally designated 170, which is attached to the suture introducerhousing 24 (see FIG. 3). Each sector of the arm actuator assembly 170 issubstantially identical. FIGS. 28-31 show that the arm actuator handleis comprised of three pieces: a button 172, a cylindrical guide 174, anda catch 176.

The button 172 comprises an actuation post 178 extending centrally froma closed end of a cylindrical body 180. The cylindrical body 180 issized to longitudinally slide in the guide 174. Three button tabs 182are spaced equally around the outer surface of the cylindrical body atthe end opposite the actuation post 178. Thus, there is one button tab182 in each sector.

The catch 176 comprises three catch tabs 184 corresponding to the threebutton tabs 182, a cylindrical body 186 which is sized to fit rotatablyinside the cylindrical body 180 of the button 172, and a control ring188 at an end of the cylindrical body 186 for engaging the three buttontabs 182. The control ring 188 is at the end of the catch 176corresponding to the end of the button 172 having the button tabs 182,and the catch tabs 184 which rotate from sector to sector extendradially from the central ring 188.

The guide 174, which is attached at its proximal end to the housing, hasthree channels 190 and three notches 192, and the guide 174 is open atboth ends; so that the button 172 protrudes from the proximal end, andthe catch 176 can extend from the opposite (distal) end. There is onechannel 190 in each sector with a notch 192 adjacent thereto. The buttontabs 182 and the catch tabs 184 are slidable within the channels 190,each button tab 182 stays in the same channel 190 while each catch tabs184 is rotated from a channel 190 to a notch 192 and to another channel190 during operation.

As indicated, the outer diameter of the button 172 is sized to slideinside the guide 174. Preferably, there is a button gap 194 between thebutton 172 and the guide 174. The diameter of the control ring 188 issized to rotate freely within the guide 174 with minimum clearance, andthe catch cylindrical body 186 is sized to rotate and slidelongitudinally inside the button cylindrical body 180 with minimumclearance. This leaves a relatively large catch gap 196 between thecatch cylindrical body 186 and the guide 174. Therefore, the length ofthe catch cylindrical body 186 is preferably long enough so that it isnever withdrawn from the button cylindrical body 180 during operation.

Because there is a button gap 194 between the button cylindrical body180 and the guide 174, the button tabs 182 have a thickness sufficientto extend across the gap 194 and into the channels 190. Thus, the buttontabs 182 also overlap the diameter of the control ring 188, so that thebutton tabs 182 can engage the control ring 188. The bottom surface 195of the button 172 is contoured to mate with the control ring 188. Thecatch tabs 184 have a diameter and thickness so that they slide in thechannels 190 and fit into the notches 192. Preferably, the outerdiameter of the guide 174 is the largest diameter thereby assuringadequate clearance for translation of the button 172 and catch tabs 184.

In FIGS. 28, 32, and 33, the catch 176 starts out in a proximal positionwith the catch tabs 184 in the channels 190 as shown in FIG. 32. Arotation spring 198 is held in compression between fixed plate 200,which is attached to the housing 24, and the catch 176. The rotationspring 198 biases the catch 176 in the proximal direction, whichcorresponds to a retracted suture clasp arm position.

The physician presses down on the actuation post 178 of the button 172causing the button tabs 182 to move distally pressing against the catchtabs 184 and control ring 188 thereby moving the catch tabs 184 distallyuntil the catch tabs 184 are beyond the distal edge 203 of the channels190. At this point, the catch 176 rotates in the direction of arrow 202in FIG. 32. The rotation is created by the rotation spring 198 pushing atop angled surface 204 of the catch tab 184 against the bottom angledsurface 206 of the button tabs 182. As the catch 176 rotates, it alsotranslates upwardly because of the angled surfaces. This prevents thecatch 176 from rotating past the notch 192.

The physician then releases the actuation post 178 allowing the rotationspring 198 to push the catch tabs 184 against the angled notch surface208 and rotate the catch tabs 184 until they contact the vertical notchstops 210 as illustrated in FIG. 28. In this rotational position,V-shaped depressions 212 on the control ring 188 are aligned with thechannels 190 of the guide 174. When the catch tabs 184 are in thenotches 192, the suture clasp arms 28, 30 are in a deployed position.

To retract the needles 136, the physician again depresses the actuatingpost 178, so that the button tabs 182 engage the V-shaped depressions212 in the control ring 188 located between the catch tabs 184. Thispushes the catch tabs 184 below the bottom of the guide 174. Therotation spring 198 pushing upward on the guide 174 causes the slidesurface 214 of the V-shaped depression 212 to slide across the bottomsurface of the button tab 182 causing the catch tabs 184 to rotate andmove upwardly until they engage the angled bottom return surfaces 216 ofthe guide 174. After the physician releases the actuation post 178, therotation spring 198 continues to force the catch tab 184 to slide overthe return surface 216 until the catch tab 184 reaches the channel 190and the spring 198 forces the catch tab 184 upwardly into the channel190 thereby retracting the suture clasp arms 28, 30. As shown in FIG.33, a button spring 218 can be provided between the catch 176 and thebutton 172 to return the button 172 to an upward position after it isreleased. If the button spring 218 is used, the button tabs 182 contactthe tops of the channels 190 preventing the button 172 from coming offthe assembly.

The suture clasp arms 28, 30 are completely deployed when the catch tab184 is in the notch 192 against the notch stop 210. For the operation ofthe actuator assembly, the catch tab 184 is pushed below this levelseveral times. To prevent the arms 28, 30 from going past a fullydeployed position, a resilient member 220 is placed in the actuating rod50. Once the suture clasp arms 28, 30 reach the fully deployed position,their further motion is restricted as described above. As the catch tab184 is pushed below the position corresponding to the fully deployedposition, the resilient member 220 is compressed allowing the catch tab184 to be moved the rest of the way below the bottom surface of theguide so that it can rotate to the next position. This prevents damageto the spreader 102, bending the actuating rod 50, and risk of injury tothe vessel 16.

To allow the catch 176 to begin rotating after it clears the bottom ofthe channel 190 or the bottom of the vertical notch stop 210. The vertex222 of the button tab 182 is not aligned with the bottom of the V-shapeddepression 212 when the V-shaped depression 212 is aligned with thechannel 190. The vertex of the depressions 212 is positioned to a sideof the vertex of the button tab 182 in the rotational direction, so thatthe catch 176 is allowed to rotate until it is underneath the shallowend of the return surface 216 of the guide 174. Similarly, when thecatch tab 184 is inside the channel 190, the angled surfaces 224 of thecontrol ring 188 corresponding to the catch tab 184 continue past thecatch tabs 184 to again allow initial rotation of the catch 176 untilthe catch tab 184 is beneath the shallow end of the notch surface. Thus,the catch tab 184 can rotate underneath the shallow end of the notch 192before the button tabs 182 contact the lowest point of the control ringsurfaces 224 and rotation is restricted. When the rotation isrestricted, the actuation post 178 is released raising the button tab182 out of the way, and the catch 176 can complete its rotation.

The operation of the device is illustrated in sequence by FIGS. 1, 2 and34 through 36. After the medical procedure, the introducer sheath 6 isleft in place, and the suture introducer housing 24 is inserted into theintroducer 6 and introduced into the artery 16 as shown in FIGS. 1A and1B. The actuation post 178 is then depressed, as illustrated by arrow240 in FIG. 35 to deploy the suture clasp arms 28, 30 outwardly asillustrated by arrows 242 so that portions, preferably the ends, arepositioned on opposite sides of the opening 26 with the suture 40extending transverse to the flow of blood.

The introducer 6 is then removed, leaving the suture introducer housing24 with the suture clasp arms 28, 30 deployed inside the artery 16. Theopening 26 in the vessel 16 closes around the housing 24 after theintroducer 6 is removed. In FIG. 38, the suture introducer housing 24 isthen oriented so that the arms 28, 30 extend transversely to the flow ofblood through the vessel 16 which is illustrated by arrow 244. Thesuture catch assembly 36 is then inserted over the housing 24 and thestop 144 is brought into contact with the top 146 of the housing 24 asshown in FIG. 2. A physician depresses the activation ring 140 asillustrated by arrows 246 (FIG. 36) pushing the needles 136 through thevessel wall 22 and puncturing holes 248 in the vessel wall 22. Thesuture catch 38 catches the suture 40, and the suture catch assembly 36is pulled proximally as illustrated by arrows 250 (FIG. 37). The needles136 can be retracted inside the suture catch assembly 36 or leftdeployed. The suture 40 is cut from the suture catch 38 and pulled tightto remove it from the housing 24.

The suture clasp arms 28, 30 are retracted by depressing the actuationpost 178 again, and the suture 40 is pulled tight simultaneously withthe housing 24 being pulled out of the artery 16. Alternatively, thelength of the actuation post 178 is set to correspond with the height ofthe depressed activation ring 140. Thus, when the activation ring 140 isdepressed, the actuation post 178 is simultaneously depressed for thesecond time thereby retracting the arms 28, 30 simultaneously withpulling the suture catch assembly 36 proximally.

With the suture catch 38 removed, the pattern of holes shown in FIGS. 38and 39 is left. As stated above, the suture 40 closes the artery vesselopening 26 transverse to the flow of blood. This is the most efficientdirection to close the opening 26. If additional suture clasp arms areutilized, it is preferred that they make additional holes around thecircumference of the opening as shown in dashed lines in FIG. 38, sothat sutures again pull the opening 26 closed in a direction transverseto the flow of blood.

The present invention could be similarly used to close a patent ductusarteriosus, a patent foramen ovale, a heart defect, a puncture wound inthe skin, and other tissues requiring suturing. For example, for closureof a heart septal defect such as an atrial septal defect (ASD), thesuturing device may be used to close the defect opening by approximatingthe tissue surrounding the defect opening. Access to such heart septaldefects can be provided by inserting a catheter including the suturingdevice into the right atrium via the inferior vena cava and the femoralartery. Alternatively, access to such heart septal defects can beprovided by inserting the catheter including the suturing device intothe right atrium via the superior vena cava and the subclavian vein orinternal jugular vein. Once the suture clasp arms 28, 30 are deployedand the suture 40 is positioned on the left-atrial side of the ASD, theneedles 136 can be extended to puncture through the tissue of the septalwall surrounding the ASD to engage the suture 40 with the suture catches38. Retracting the needles 136 then pulls the suture 40 through theseptal wall, and further tension applied to the suture 40 closes the ASDby approximating the surrounding tissue of the septal wall. Similarprocedures can be used to repair other septal defects such as patentforamen ovales, ventricle septal defects (VSD), endocardial cushiondefects, or septal defects existing in conjunction with Tetralogy ofFallot. As discussed below in conjunction with FIGS. 82-84, where thesize of the septal defect is so large that approximation of the tissuesurrounding the septal defect would result in excessive distortion ofthe cardiac tissue, the suturing device may be used in conjunction witha patch.

An alternate configuration of the suturing device is shown in FIG. 40.The device comprises a pair of suture clasp arms 270 attached to the endof an actuating rod 272 in accordance with one of the above describedconfigurations. The actuating rod extends through a needle cover 274 andslidably through a needle actuator 276 to a suture arm deployment handle278. Near the deployment handle 278 the actuating rod 272 has, aseverable junction 279. The junction 279 is threaded or snap fitallowing the actuating rod 272 to be quickly separated and joinedthereby quickly removing or attaching the handle 278 from the remainderof the device. The actuating rod 272 can, in the alternative, have ajunction where it enters the needle cover 274.

Needles 280 are held near their distal ends by a needle guide 282 andpass through a stop 284 that limits the deployment distance of theneedles 280. The needles 280 fixably attaching to the needle actuator276. A spring 286 is interposed between the stop 284 and the needleactuator 276 to bias the needles 280 in a retracted position. A secondstop 288 is fixed to the actuating rod 272 on the opposite side of theneedle actuator 276 to prevent the needles 280 from being pulled out ofthe needle guide 282.

The actuating rod 272 terminates at a thumb ring 290 separated from thedistal end of the suture arm deployment handle 278 by a thumb ringspring 292 which biases the thumb ring 290 in a proximal position whichcorresponds to a retracted position of the suture clasp 270. The handle278 also comprises two finger rings 294, 296 on opposite sides of thehandle allowing a physician to smoothly overcome the force of the thumbring spring 292.

In operation, the distal portion of the device, from the needle cover274 to the suture clasp arms 270, is inserted into the introducer 6 withthe handle 278 detached. The introducer 6 is removed and the handle 278is attached to the device by connecting the actuating rod 272. The thumbring 290 is pushed distally to deploy the suture clasp arms 270. A clip298 hooks onto a clip ring 300 to lock the suture clasp arms 270 in thedeployed position.

The actuating rod 272 includes a resilient member 302 (shownschematically), which functions, as described in the previousconfigurations, to prevent the suture clasp arms 270 from moving pasttheir deployed position. The resilient member 302 can simply comprise aspring, or a spring housing can be provided on one part of the actuationrod 272 to receive a spring and a slidable plunger therein. The plunger,which is provided on the opposite part, slides to a maximum distalposition defined by the spring housing and is biased in that position bythe spring. When the suture clasp arms 270 reach a deployed position,the plunger is then forced into the spring housing, compressing thespring and allowing the upper portion of the actuation rod 272 to traveldistally without forcing the suture clasp arms 270 past a deployedposition or bending the actuation rod 272. A thumb ring stop 304prevents the thumb ring 290 from being pushed beyond a point for whichthe resilient member 302 could compensate.

With the suture clasp arms 270 deployed, the physician grasps the needleactuator 276, which has a central curved indented surface 306 to make iteasy to grasp, and pushes the needle actuator 276 distally. The needles280 are pushed into the vessel 16 and catch the suture 40 as describedin one of the above configurations. The stop 284 prevents the needles280 from penetrating too far and damaging the vessel 16. The spring 286pushes the needles 280 back to a retracted position when the needleactuator 276 is released.

With the suture 40 held by the needles 280, the thumb ring 290 is pushedin a direction transverse to the length of the actuating rod and awayfrom the clip 298 as illustrated by arrow 308 to release the clip 298and retract the suture clasp arms 270. The entire device is retracted,the suture 40 cut from the needles 280, and the suture 40 tied to closethe opening 26. Because the handle 278 is detachable, the handle 278could be used in conjunction with the above described configurations. Insuch a case, the arm actuator assembly would be removed, and theactuating rod 50 would extend through the top of the housing 24. The endof the actuating rod 50 would be modified to connect to the handle 278.

Embodiments of FIGS. 1C-1D and 41-50

In the embodiments described above, the suture introducer housing 24 andthe suture catch assembly 36 consist of two separate pieces, wherein thesuture catch assembly 36 operatively fits around the suture introducerhousing 24. As described above with reference to FIGS. 1A-1B, in theseembodiments, the physician fully removes the original CSI 6 beforeinserting the suture catch assembly 36 to penetrate the blood vesselwall and catch the ends of a suture. The removal of the CSI 6 and theintroduction of the suture catch assembly 36 may disturb the flesh 14 orenlarge the incision 20 and add to the complexity of the procedure.

The embodiments illustrated in FIGS. 1C-1D and 41-50, however, do notrequire the full removal of the original CSI 6 (used for the originalpercutaneous approach procedure, such as an angioplasty/angiographyprocedure) in order for the device to catch the ends of a suture.Rather, as depicted in FIG. 41, the distal portion of the device 520passes through the CSI 6 and the flesh 14 of the patient's thigh 12 withminimal disturbance to the flesh 14, and through the second incision 26into the femoral artery 16. Any disturbance to the flesh 14 issignificantly reduced because the CSI 6 is not removed and a suturecatch assembly is not slid down over a suture introducer housing throughthe flesh 14, as in the embodiments described above with reference toFIGS. 1A-1B and 2-40.

FIGS. 41-48 illustrate the device 520 depicted in FIG. 1C-1D where thesuture introducer housing and the suture catch assembly are integratedinto a single suture insertion and retraction device 520. This suturingdevice 520 may comprise a one-piece suture insertion and retractionhousing 515 as shown in FIG. 48, or may comprise a suture introducerhead 522 attached to the distal end of a hollow elongated body 514 asshown in FIG. 41.

With reference to FIG. 41, the suture introducer head 522 and the hollowbody 514 are narrower in diameter than the configurations illustrated inFIGS. 1A-1B and 2-40 because the suture clasp member 500 and the needles546 reside in the same longitudinal space. In other words, the needles546 share the same housing as the suture clasp member 500 (while theyare all in their retracted state), but are higher up (proximally) in thesuturing device 520 than the suture clasp member 500. An importantfeature of this embodiment is that it uses flexible needles 546 whichbend outward, away from the axis of the device 520, when in the extendedposition (as shown in FIG. 47).

The dimensions of the suturing device 520 may vary according to thesuture site and the biological tissue intended to be sutured. In oneconfiguration, the diameter of the suture introducer head 522 is about0.105 inches, and the diameter of the hollow elongated body 514 is about0.098 inches.

As shown in FIGS. 42, 46 and 47, the suture introducer head 522 has twoneedle ports or apertures 510 formed therein (one per needle 546)proximal to the suture clasp arms 524. Each needle port includes aneedle guiding portion 512 (“needle guide”), in the form of an outwardlycurved groove or channel, which guides the corresponding needle 546along a particular path. The needle guides 512 may be formed within thesuture introducer head 522 (as shown in FIG. 41) as part of a mold, ormay be separate pieces (not shown) that are inserted into the sutureintroducer head 522 during manufacture.

Another advantage of the embodiments illustrated in FIGS. 41-48 is therequired size of the initial incision 20 into the patient's body and thediameter of the introducer sheath 6 used to insert the device 520 may bereduced. The size of the suture device 520 may vary depending on theapplication and the size of the vessel incision 26.

FIG. 46 shows a preferred configuration of the hollow elongated body 514with five lumens. Two of the lumens 516 are used to house the needles546 (FIG. 41). Another lumen 530 is used to house the actuating rod 50.Another lumen 532 is used to hold the length of the suture 40 to preventthe suture 40 from becoming tangled. Alternatively, the suture 40 may bestored in the actuating rod lumen or in a hole drilled into the sutureclasp arm 500.

The fifth lumen 534 is preferably used for ‘bleed back,’ which lets thephysician determine whether the distal end 504 of the suture introducerhead 522 is still positioned in the artery 16 after the physicianremoves the catheter sheath introducer (CSI) 6. Bleed back isaccomplished by the hole 540 (FIG. 45) at the distal end 504 of thesuture introducer head 522, the suture clasp arm apertures 508 and anyother openings in the suture introducer head 522. The direction of bloodflow for bleed back is shown by the dashed arrows in FIGS. 41 and 48. Ifthe distal end 504 of the introducer head 522 is still in the artery 16,the blood pressure measured by the blood coming up into the hole 540will be much greater than if the distal end 504 is not in the artery 16.In one embodiment, the bleed back lumen 534 extends to a port (notshown) at a proximal portion of the device, and the physician canobserve the blood pressure through bleed back lumen 534 by monitoringblood flow from the port. For example, the bleed back lumen may beattached to a balloon which inflates when the distal portion 504 of thesuture introducer head 522 is within the blood vessel 16. In anotherembodiment, a pressure sensor is associated with the blood flow lumen534 to provide the physician with a numeric reading. Alternatively, thefifth lumen 534 may be used to inject medication or for diagnosticpurposes.

In a preferred embodiment, two thin stripes 538 (only one shown in FIG.46) are marked on the exterior of the elongated body 514 which denotethe circumferential location of the two needles 546. These stripesextend along a portion of the elongated body 514 which is outside thepatient's body. These stripes help the physician to align the needles546 with the axis of the blood vessel 16, so that the needle incisions248 (FIG. 47) will be longitudinally aligned. As described above forFIG. 38, the suture 40 closes the artery vessel opening 26 transverse tothe flow of blood. This is the most efficient direction to close theopening 26. Proper insertion of the needles 546 reduces the risk ofdamage to the vessel walls 22, 506. Alternatively, there may be only onestripe to denote the circumferential location of one of the two needles546. The physician will know the circumferential location of the otherneedle 546 because the needles 546 are 180 degrees apart.

As illustrated in FIG. 46, the exterior surface of the elongated body514 includes a marker 539 which denotes the proximal position to whichthe CSI 6 should be partially withdrawn (after the distal portion of thesuturing device 520 has been inserted into the blood vessel 16) toexpose the needle apertures 510. The partial withdrawal of the CSI 6 isdescribed below. The marker 539 is shown as a visual marker, but mayadditionally or alternatively be in the form of a ridge, groove, orother physical structure which interacts with a corresponding structureof the CSI to allow the physician to position the CSI using the sense offeel. For example, the CSI 6 and elongated body 514 could be configuredto releasably engage or interlock with one another when the CSI reachesthe proper position along the body 514. A specially formed CSI whichincludes such an interlocking structure is included within the scope ofthe invention. One or more additional longitudinal markers (not shown)could be provided along the body 514, distal to marker 539, to indicateother relative positions of the CSI and the body 514, such as theposition at which the retractable arms 524 are exposed outside the CSI.

As illustrated in FIGS. 41-43, the device 520 includes a single,resilient suture clasp member 500 attached to the actuating rod 50. Thisresilient suture clasp member 500 is preferably of a unitaryconstruction as shown. The suture clasp member 500 comprises a center orhinge portion 542 and two suture clasp arms 524 (one for each needle546). Each suture clasp arm 524 has a suture clasp 544 at the endthereof.

The hinge portion 542 of the suture clasp member 500 acts as a “livinghinge” because it has a memory which causes the member 500 to return toa partially open, unretracted position (FIG. 42) when a force (appliedvia rod 50) is released. This can be seen in FIGS. 41 and 42. In FIG.42, the suture clasp member 500 is deployed in the artery 16 in itspredisposed (relaxed or natural) position. In FIG. 41, the suture claspmember 500 is retracted into the suture introducer head 522 in itscompressed (stressed or tensed) position. The arms 524 are moved to theretracted position by applying a distal force to the actuator rod 50,which causes the arms to contact deflection surfaces 518 (FIG. 42).

This suture clasp member 500 is preferably composed of a resilient shapememory material such as NITENOL. The suture clasp member 500 mayalternatively be composed of another material with spring-likecharacteristics, such as plastic, spring steel, stainless steel or anyvariations thereof. Further, the suture clasp member 500 could becomposed of two arms that are hingedly connected to the actuating rod 50without the use of a resilient hinge, as shown in FIGS. 43C and 43D anddescribed below.

The living hinge configuration is easily adaptable to having three armsspaced at 120 degrees or four arms (as in FIGS. 58 and 59) spaced atninety degrees. If there are three arms, then there are preferably 3needles 546 and six lumens in the elongated body 514. Thus, otherconfigurations and numbers of arms can be incorporated into the deviceto accomplish the specific needs of the application.

The needles 546 are flexible and preferably made from a material withshape memory, such as SUPERFLEX NITENOL. Alternatively, the needles 546may be composed of spring steel, surgical stainless steel or anyvariation thereof. The diameter of the needles 546 is preferably about0.019 inches, but needles with other diameters may be used in accordancewith the present invention.

When the needles 546 are advanced distally and come in contact with theneedle insertion guides 512, the needle insertion guides cause theneedles 546 to bend radially outward. The needles 546 also preferablyfurther bend slightly (radially outward) when they come in contact withthe angled surfaces 545 of the suture clasp arms 524, as shown in FIG.47. When the needles 546 are retracted into the needle lumens 516, theyresume a straight configuration as a result of their resiliency.Although the embodiment of FIGS. 41-48 preferably uses flexible needleswhich bend during deployment, it is contemplated that non-bendingneedled, which may be either straight or curved, could alternatively beused.

As illustrated by the cut-away views of FIGS. 43A and 43B, the actuatingrod 50 attaches to the resilient suture clasp member 500 by a pivot pin502. The actuating rod 50 in this configuration preferably comprises asingle shaft (as shown), but may comprise a plurality of shafts in otherconfigurations.

FIG. 43C is a perspective view of a non-living hinge embodiment or atwo-piece suture clasp member 501. FIG. 43D is a cross-sectional view ofthe two-piece suture clasp member 501 and a ramp or spreader 523 withinthe suture introducer head 522. Alternatively, the hinge portion of thesuture clasp arms 525, 525′ with suture clasps 544 may be similar to ahinge portion shown in FIG. 53, which is described below. The spreader523 may be a separate piece attached within the suture introducer head522. Alternatively, the spreader and suture introducer head 522 maycomprise a single molded piece.

The length of the suture clasp arm 525 is preferably about 0.174 inches.The length of both of the suture clasp arms 525, 525′ together in theirfully extended position (deployed with both arms parallel to each other)is preferably about 0.288 inches. In other configurations of the sutureclasp arms 525, 525′, the dimensions may vary.

In FIG. 43D, when the actuating rod 50 pulls the two-piece suture claspmember 501 proximally (while the suture clasp member 501 is in itsretracted position), the distal edges of the spreader 523 come incontact with the tips of the suture clasp arms 525, 525′. The spreader523 causes the two suture clasps arms 525, 525′ to open radially outwardrelative to the actuating rod 50. In a preferred method of operation,the actuating rod 50 continues to pull the suture clasp member 501proximally until the center of the suture clasp member 501 fits into thecenter of the spreader 523. To retract the suture clasp arms 525, 525′into the suture clasp member's retracted position, the actuating rod 50is advanced distally, and the interior edges 518 of introducer head 522come in contact with the suture clasp arms 525, 525′ The interior edges518 of introducer head 522 cause the two suture clasp arms 525, 525′ toretract radially inward relative to the actuating rod 50. The generaluse and operation of the two-piece suture clasp member 501 is similar tothe use and operation of the suture clasp member 500 shown in FIG. 43A,as described below.

The proximal portion of the suturing device 520 preferably includes ahandle which allows the physician to externally operate the suture clasparms 524 and the needles 546 inside the blood vessel 16. This handlepreferably has three actions: a first action in which the actuating rod50 applies a proximal force to the hinge portion 542 to deploy andmaintain the arms 524 in a fully outward position (FIG. 47); a secondaction to advance the needles 546 distally (FIG. 47) and pull theneedles 546 back proximally using one or more springs; and a thirdaction in which the actuating rod 50 applies a distal force to the hingeportion 542 to retract the arms 524 (FIG. 41 or 48).

Alternatively, the handle may be a 2-action handle in which one of thetwo actions is a combination of two of the three actions described abovefor the 3-action handle. For example, in a first action, the actuatingrod 50 applies a proximal force to the hinge portion 542 to deploy andmaintain the suture clasp arms 524 in a fully extended state of FIG. 47.With the arms 524 in this fully extended position, the needles 546automatically advance distally (FIG. 47) and retract proximally tocapture the looped ends of the suture 40. In a second action for this2-action handle, the actuating rod 50 applies a distal force to thehinge portion 542 to retract the arms 524 (FIG. 41 or 48). This 2-actionhandle is suited for physicians with more experience in operating thissuture device 520. It will be apparent to one of ordinary skill in theart that a 1-action handle or a 4-action handle (inserting andwithdrawing the needles 546 as two separate actions) could be used, orthat separate handles or triggers could be provided for differentactions.

FIG. 49 is a cross-sectional view of one embodiment of a handle 550operatively attached to the proximal end of the hollow elongated body514 of FIG. 41 or the single suture insertion and retraction housing 515of FIG. 48 or the device of FIG. 52A. FIG. 50 is a perspective view ofthe handle 550. FIG. 57 is a perspective view of the handle 550 of FIG.49. The handle 550 comprises an actuating rod aperture 551, a mainhousing 552, a pair of finger grips 554, a suture clasp arm piston 556with a locking groove 576, a needle piston 560 with at least one raisedkey portion 562, a releasor 568 with a locking stopper 572, a pivot pin570, a releasor support 574, a compression spring (not shown)operatively positioned in a spring recess 578 between the suture clasparm piston 556 and the needle piston 560, a needle piston supportcylinder 580 with at least one grooved recess 564 and needle clamps 584.

In one configuration, the housing 552 is attached to or is acontinuation of the hollow elongated body 514 of FIG. 41 or the singlesuture insertion and retraction housing 515 of FIG. 48. In anotherconfiguration, the housing 552 is separate from the hollow elongatedbody 514 or single suture insertion and retraction housing 515. In thisconfiguration, the actuating rod 50 connects the housing 552 with thehollow elongated body 514 or single suture insertion and retractionhousing 515.

A proximal portion of the actuating rod 50 (FIGS. 41 and 48) slidesthrough the actuating rod aperture 551 at the distal end of the housing552. The proximal end of the actuating rod 50 is attached to the distalend 558 of the suture clasp arm piston 556, which is slidably receivedwithin the main housing 552. A compression spring (not shown) resides inthe spring recess 578 of the housing 552 between the suture clasp armpiston 556 and the needle piston 560 and simultaneously exerts twoforces: a distal force on the suture clasp arm piston 556; and aproximal force on the needle piston 560.

The needle clamps 584 of the needle piston 560 hold the proximal ends ofthe needles 546. The needle piston 560 is slidably received within adistal portion of the housing 552. The needle piston support cylinder580 is attached to the housing 552 and preferably does not move relativeto the housing 552.

The releasor 568 pivots radially inward and outward on the pivot pin570. The releasor support 574 exerts a radially outward force on thereleasor 568. This force causes the releasor 568 to pivot and thelocking stopper 572 to fall into the locking groove 576 of the sutureclasp arm piston 556 when the locking groove 576 is aligned to receivethe locking stopper 572. The releasor support 574 is preferably made ofa resilient shape memory material such as NITENOL. The releasor support574 may alternatively be composed of another material with spring-likecharacteristics, such as plastic, spring steel, stainless steel orvariations thereof. Other embodiments of the handle are described belowwith reference to FIGS. 57, 60 and 61.

The use and operation of the device 520 and the handle 550 will now bedescribed with reference to FIGS. 1C-1D and 41-50. In operation, withthe CSI extending into the patient's artery 16, the physician insertsthe suture introducer head 522 through a catheter sheath introducer(CSI) 6 and into the artery 16 (FIGS. 1C-1D). The CSI 6 is thenpartially withdrawn along the body 514 of the suturing device 520 toremove the CSI 6 from the artery 16 and expose the needle apertures 510,as shown in FIG. 41. There are one or more markings 539 (FIG. 46) on theexterior surface of the elongated body 514 which indicate how far thephysician should withdraw the CSI 6 to expose the needle apertures 510.

The distal end 504 of the introducer head 522 has a smooth, roundedsurface to prevent injury to the opposite vessel wall 506 when insertingthe introducer head 522. In addition, the blood flow in the artery 16 isuninterrupted because the introducer head 522 does not occlude theartery 16. The physician may use the aperture 540 at the distal end ofthe suture introducer head 522 and the bleed back lumen 534 to determinewhen the distal end 504 of the suture introducer head 522 is in theartery 16.

While the introducer head 522 is inserted into the artery 16 in FIG. 41,the actuating rod 50 holds the resilient suture clasp member 500 in itscompressed position within the introducer head 522. The actuating rod 50applies a downward force while the interior edges 518 of the introducerhead 522 apply an inward force on the two suture clasp arms 524. Thecombination of these two forces cause the hinge portion 542 of sutureclasp member 500 between the two arms 524 to elastically deform orcompress. The suture clasps 544 hold the looped ends of a suture 40 inthe angled slot of the suture clasps 544 as shown in FIGS. 41-43A. Thelooped ends of the suture 40 are held securely by the suture clasps butare positioned for easy removal by the suture catches 38 of the needles546.

When the distal portion of the device 520 (FIGS. 41 and 48) is properlypositioned in the blood vessel 16, the physician may deploy the sutureclasp arms 524 (FIG. 42) by pulling the finger grips 554 in a proximaldirection relative to the housing 552 (FIG. 50). A physician may pullthe suture clasp arm piston 556 proximally by placing the physician'sindex and middle finger around the finger grips 554 and pushing on theproximal end 582 of the housing 552. This action is similar to operatinga standard syringe. This motion compresses the spring (not shown) in thespring recess 578 of the handle 550 in a proximal direction. As thesuture clasp arm piston 556 moves proximally, the actuating rod 50 movesin a proximal direction relative to the elongated body 514 or housing515. This is shown by the arrows in FIG. 42. This motion causes thesuture clasp member 500 to deploy or open to its predisposed or naturalposition as shown in FIG. 42. The suture clasp arms 524 deploy out ofthe introducer head 522 into the blood vessel 16 through two sutureclasp arm apertures 508 (FIG. 42), one on either side of the introducerhead 522.

When the physician pulls the suture clasp arm piston 556 a certainproximal distance relative to the housing 552, the locking stopper 572at the distal end of the releasor 568 moves radially inward and fallsinto the locking groove 576 of the piston 556. The locking stopper 572,in combination with the locking groove 576, prevents the suture clasparm piston 556 from advancing distally. The force of the spring inrecess 578 prevents the suture clasp arm piston 556 from movingproximally. The locking of the suture clasp arm piston 556 stabilizesthe suture clasp arms 524 in a locked position before the needles 546are advanced distally.

In this locked position, the suture clasp arms 524 preferably havereached their fully extended position, as shown in FIG. 47. In the fullyextended position, the actuating rod 50 (attached to the suture clasparm piston 556) has pulled the resilient suture clasp member 500 up, andthe proximal inside edges 536 of the aperture 508 have come in contactwith the arms 524 of the suture clasp member 500. This is shown in FIG.47. The pulling of the actuating rod 50 and the stationary inside edges536 of the apertures 508 cause the arms 524 to bend backward until thearms 524 are longitudinally aligned with each other, as shown in FIG.47. Thus, the resilient suture clasp member 500 is deformed from itsnatural configuration again, but this time in an extended positioninstead of a compressed position. In this extended position, thephysician may move the suturing device 520 proximally so that the arms524 touch the interior of the vessel wall 22 while the needles 546advance distally and capture the ends of the suture 40 from the sutureclasps 544.

Next, the physician twists the needle piston 560 clockwise orcounter-clockwise until the raised key portion 562 of the needle piston560 matches the grooved recess 564 of the needle piston support cylinder580. The grooved recess 564 of the needle piston support cylinder 580allows the raised key portion 562 of the needle piston 560 to advancedistally. Otherwise, the needle piston 560 may not be advanced distallyif the raised key portion 562 does not match the grooved access 564. Theneedle piston support cylinder 580 and the raised key portion 562 of theneedle piston 560 prevent the needles 546 from advancing distallyprematurely or improperly. Premature or improper insertion of theneedles may cause damage to the patient's surrounding tissue 14 (FIGS.1B and 1D) or the blood vessel 16.

When the raised key portion 562 of the needle piston 560 matches thegrooved recess 564 of the needle piston support cylinder 580, thephysician may advance the proximal end of the needle piston 560 (withthe physician's thumb or palm) in a distal direction relative to theproximal end 582 of the housing 552. This motion compresses the springin the spring recess 578 in a distal direction. When the needle piston560 advances distally, the needles 546 and the suture catches 38 on theneedles (FIG. 47) also advance distally.

The paths taken by the needles 546 are illustrated in FIG. 47. Theneedles 546 slide along the needle housings 516 (or needle lumens) andout of the suture device 520 through needle apertures 510. When theneedles 546 come in contact with the needle insertion guides 512, theneedles 546 begin to bend radially outward. As the needles 546 exit,they are guided at a radially outward, acute angle away from theactuating rod 50 by the needle insertion guides 512. The angle of theneedle deflection is preferably 13.2 degrees. Deflection angles in theranges of 10 to 15 degrees and 5 to 20 degrees are also contemplated.

The needles 546 then penetrate the vessel wall 22 at an angle bycreating incisions 248 on either side of the main vessel incision 26.The needles 546 also preferably bend slightly (radially outward) whenthey come in contact with the suture clasp arms 524. The combination ofthe suture clasps 544 and the suture catches 38 on the needles 546creates a lock on the looped ends of the suture 40, such that the sutureends will not fall off while the needle 546 engages the suture claspmember 500.

The physician advances the needle piston 560 distally until theresistance of the compression spring prevents the needle piston 560 fromadvancing any further distally. In this position, the needles 546 aresufficiently advanced in the blood vessel 16 such that when the needles546 are pulled back proximally, the suture catches 38 on the needles 546will catch the looped ends of the suture 40 from the suture clasps 544.As shown in FIG. 47, the clasp arms 524 hold the suture loops away fromthe suture introducer head 522, so that the needles 546 pierce thevessel 22 and catch the suture loops outside the perimeter of the sutureintroducer head 522.

After the physician advances the needle piston 560 to its farthestdistal position, the physician releases the needle piston 560. Thecompressed spring causes the needle piston 560 to immediately springback proximally. This motion causes the distal portion of the needles546 to immediately spring back proximally into the needle housing 516with the looped ends of the suture 40 attached to the suture catches 38.

The suture catches 38 on the needles 546 catch the suture loops held bythe suture clasps 544 and pull the ends of the suture 40 up through thepunctured holes 248 when the needles 546 are retracted proximally. Whenthe needles 546 are retracted into the needle lumens 516, they resume astraight configuration. As the needles 546 retract, a segment of thesuture 40 is released (as a result of the tension caused by theretracting needles 546) through an aperture 540 at the distal end 504 ofthe suture introducer head 522 and into the artery 16.

To retract the suture clasp arms 524 (FIGS. 41 and 48), the physicianpresses the proximal portion of the releasor 568 in a radially inwarddirection. This motion causes the releasor 568 to pivot. The lockingstopper 572 moves radially outward and releases the locking groove 576.The force of the compressed spring causes the suture clasp arm piston556 and the actuating rod 50 to advance distally. Together with theproximal interior edges 518 of the introducer head 522, the downwardforce of the actuating rod 50 causes the resilient suture clasp member500 to retract into its compressed position. As shown in FIGS. 44 and45, the suture clasp arms 524 retract into respective apertures orgrooves 508 on the exterior surface of the introducer head 522. In thisretracted state, the arms 524 are substantially parallel with theelongated body 514. As FIG. 44 illustrates, the exterior surfaces of thearms 524 are flush with the exterior surface of the introducer head 522.This reduces the likelihood that the arms 524 will catch on the vesselwall 22 or flesh 14 during withdrawal. The device 520 is now ready forremoval from the blood vessel 16.

The physician withdraws the device 520 out of the blood vessel 16 andout of the flesh 14 of the patient's thigh 12. After the device 520 iswithdrawn (and with the CSI 6 still in the flesh 14), the physicianpulls the ends of the suture 40 and closes the main vessel incision 26.The physician then ties at least one knot with the ends of the suture 40and slides or pushes the knot(s) down through the CSI 6 to the vesselincision 26. Alternatively, the physician may fasten a small, circularor flat stainless steel clip (not shown) to the ends of the suture 40and slide the clip down through the CSI 6 to the vessel opening 26 toclose the opening 26. The physician then cuts the unused ends (extralength) of the suture 40 and removes the cut portions. The physicianthen removes the CSI 6 from the patient's thigh 12.

Some of the advantages of the suturing device 520 shown in FIGS. 41-48will now be described in greater detail. First, the radial deployment ofthe suture clasp arms 524 (FIGS. 41-42 and 47) from the sides of thesuturing device's body, instead of deployment from the distal tip,provides an advantage over other embodiments. The device 520 shown inFIGS. 41-48 deploys its suture clasp arms 524 in a radial directionwithout extending beyond the distal end 504 of the device 520. Thus,this device 520 reduces the likelihood that the suture clasp arms 524will contact and damage the inner vessel wall 506 opposite the incision26.

Second, the locked position of the suture clasp arms 524 (as describedabove with reference to FIG. 47) provides a stable base or foundationfor holding the looped ends of the suture 40 while the needles 546 comein contact with the suture clasp arms 524 and capture the suture 40. Thesuture clasp arms 524 are locked in the locked position by the proximalforce of the actuating rod 50, the stationary inside edges 536 of theapertures 508 and the protrusions 528 at the ‘elbow’ end of each arm 524(FIG. 47). Specifically, when the suture clasp arms 524 becomesubstantially parallel with each other (i.e., each arm 524 is at anangle of approximately 90 degrees from the actuating rod 50), theprotrusions 528 at the ‘elbow’ end of each arm 524 come into contactwith each other and prevent the arms 524 from bending any further thanthe configuration shown in FIG. 47. The suture clasp member 500 cannotopen any farther, even when the needles 546 are inserted distally andcome in contact with the suture clasp arms 524. The protrusions 528prevent the suture clasp member 500 from moving unintentionally (openingany farther) when the needles 546 come in contact with the suture clasparms 524. This reduces the risk of the looped ends of the suture 40being accidentally displaced from the suture clasps 544 when the needles546 engage the suture clasps 544. Thus, the combination of forcesasserted by the actuating rod 50, the proximal inside edges 536 of theaperture 508 and the two protrusions 528 sustain the suture clasp arms524 in a rigid, locked position to facilitate the proper removal of thesuture looped ends from the suture clasps 544.

Third, the shape and position of the angled slits of the suture clasps544 in FIGS. 41-48 provide another advantage. The slits of the sutureclasps 544 in FIGS. 41-48 are angled in a proximal, radially inwarddirection. Thus, the face of the looped ends of the suture 40 face in aproximal, radially inward direction. In this configuration, there isless chance of the looped ends of the suture 40 falling off the sutureclasps 544 improperly or prematurely. When the needles 546 engage thesuture clasp arms 524, the only direction the looped ends may move is ina proximal, radially inward direction, which is in the oppositedirection of the inserted needles 546. When the needles 546 retractproximally (as shown in FIG. 47), the looped ends reliably fall into thesuture catches 38 of the needles 546. It is the proximal movement of theneedles 546 in the embodiments in FIGS. 41-48 which causes the suturecatches 38 on the needles 546 to catch the looped ends of the suture 40.This configuration does not rely on a radially outward tension in thelooped ends to fasten the looped ends onto the suture catches 38 whenthe needles 546 are inserted distally.

In the various embodiments described with reference to FIGS. 1C-1D and41-48, retractable suture clasp arms are used to hold the suture 40beyond the outer circumference of the tubular housing (and thus beyondthe boundaries of the incision 26), and flexible needles 546 are used tocapture the held suture 40 outside the outer circumference. In otherimplementations (not shown), the suture clasp assembly may be in theform of a fixed (non-moving) member which holds the suture near orwithin the circumference of the housing. In such implementations, curvedneedles may be used which pierce the vessel wall outside thecircumference of the housing and then “curve in” to capture the suture.The curved needles may then be withdrawn to pull the ends of the sutureout of the vessel wall.

FIG. 51 is a cross-sectional view of another embodiment of a handle 600attached to the proximal end of the hollow elongated body 514 of FIG. 41or the single suture insertion and retraction housing 515 of FIG. 48 orthe device of FIG. 52A. The handle 600 of FIG. 51 comprises a housing602 with a spring recess 622, a pair of external finger grips 604 (onlyone shown in FIG. 51), a suture clasp arm piston 606 with a lockinggroove 608, a releasor 612 with a locking head 610 and a needle pistonstopper 618, a pivot pin 614, a needle piston 620 with needle clamps 616and a spring 624.

The handle 600 also includes a second spring (not shown) which biasesthe releasor 612 toward a position in which the locking head 610 isengaged with the groove 608. Similar to the handle 550 shown in FIG. 50,the finger grips 604 extend outside the housing 602 to allow a physicianto move the piston 606 relative to the housing 602. The needles 546 inFIG. 51 are attached to the needle clamps 616, which is attached to theneedle piston 620. The actuating rod 50 (FIG. 41) is attached to thesuture clasp arm piston 606 in FIG. 51.

The general operation of the handle 600 shown in FIG. 51 is similar tothe operation of the handle 550 shown in FIGS. 49-50. In FIG. 51, theneedle piston stopper 618 prevents the needle piston 620 from distallyadvancing prematurely or improperly. This function is similar to thefunction of the raised key portion 562 and grooved recess 564 of thehandle 550 shown in FIGS. 49-50. In FIG. 51, the physician advances thesuture clasp arm piston 606 proximally against the biasing force of thespring 614 (by pulling the finger grips 604 proximally) to deploy thesuture clasp arms 524 (FIG. 42) until the locking head 610 of thereleasor 612 moves radially inward and falls into the locking groove608. At this point, the clasp arms 524 are in the fully deployed or openposition as in FIG. 47. This motion causes the proximal portion of thereleasor 612 to advance radially outward until the needle piston stopper618 is no longer blocking the needle piston 620. At this time, thephysician may advance the needle piston 620 distally into the recess 622to cause the needles 546 to advance distally and capture the suture 40.When the physician releases the needle piston 620, the spring 614 movesthe needle piston proximally to the outward position, causing theneedles 546 to retract with the suture 40. Finally, the physicianpresses the external lever portion of the releasor 612 to release thesuture clasp arm piston 606; this causes the suture clasp arms 524 toreturn to the retracted position, so that the device can be withdrawnfrom the artery 16.

One of ordinary skill in the art will appreciate that there are manypossible configurations of this handle attached to the proximal end ofthe device 520. In one configuration (not shown), there are at least twosprings or sets of springs (not shown), instead of the singlecompression spring as used by the handle 550 in FIGS. 49-50 and thehandle 600 in FIG. 51. In this embodiment with two springs, a firstspring exerts a proximal force on the needles 546 while a second springexerts a distal force on the actuating rod 50 inside the handle. Inanother configuration (not shown), instead of a second set of springs ora trigger, the physician manually retracts the needles 546 proximallyback into the needle housing 516. In another configuration, a handle(not shown) attached to the proximal end of the device 520 is similar tothe handle as shown in FIG. 40.

Embodiments of FIGS. 52A-59

FIG. 52A is a perspective view of the suture introducer head 522 and thehollow elongated body 514 of FIG. 41 with another embodiment of thesuture clasp arms 630, 630′. In this embodiment, the ends of the sutureare provided with special loops 41 that are configured to engage withthe needles (as described below). FIG. 52B is a cross-sectional view ofthe device of FIG. 52A. FIG. 53A-53B are perspective views of oneconfiguration of the suture clasp arms 630, 630′ shown in FIG. 52A. FIG.54 is a perspective view of the device of FIG. 52A with the suture clasparms 630, 630′ partially deployed. FIGS. 55-56 are perspective views ofthe device of FIG. 52A with the suture clasp arms 630, 630′ fullydeployed. FIG. 56 further shows two flexible needles 650 engaging thesuture clasp arms 630, 630′.

As shown in FIG. 52A, a first suture clasp arm 630 comprises a hingeportion 636 at a distal side with an aperture 642 for a pivot pin 502(FIG. 43C). The first suture clasp arm 630 further comprises a curvedportion 638 for the distal end of an actuating rod 50 (as in FIG. 43B)and the hinge portion 636 at a distal side of the second suture clasparm 630′ (FIG. 53B). The first suture clasp arm 630 further comprises anannular recess 632 for holding a suture looped end 41 and for receivingthe distal portion of a needle. The arm 630 further comprises a slit 640for the length of the suture 40, and a sloped end 634. The distal sideof the arms 630, 630′ are connected to the actuating rod 50 via a pivotpin 502 (FIG. 43C) such that the proximal sides of the arms 630, 630′may move away from the suture introducer head 522, as shown in FIG. 54,to a position where the proximal sides are fully extended outwardly awayfrom the distal sides of the arms 630, 630′ shown in FIGS. 52A-52B. Theextended proximal sides may also be retracted towards and into thesuture introducer head 522 to a retreated position (similar to theposition shown in FIG. 41).

FIG. 53B illustrates the second suture clasp arm 630′, which is theother half of a two-arm suture clasp member. The second suture clasp arm630′ is similar to first suture clasp arm 630 except the second sutureclasp arm 630′ does not have a curved portion 638 for the distal end ofan actuating rod 50 (as in FIG. 43B).

In one embodiment, the length of the first suture clasp arm 630 is about0.174 inches. In one embodiment, the length of both of the suture clasparms 630, 630′ together in their fully extended position (deployed withboth arms parallel to each other) is preferably about 0.288 inches. Inother configurations of the suture clasp arms 630, 630′, the dimensionsmay vary.

As shown in FIGS. 55-56, each of the flexible needles 650 comprises anelongated shaft, a pointed, generally conical penetrating distal tip654, and a groove or shoulder 652 at the base of the distal tip 654 nearthe distal end. The circumference of the looped end 41 is slightlysmaller than that of the base of the conical tip 654, so that the needlegroove 652 acts as a detent mechanism or suture catch. In a preferredconfiguration, the grooves 652 extend around the complete circumferenceof the needles 650. In other configurations, the grooves 652 arepartially circumferential along the radial edge of the needles 650. Theloops 41 correspond generally in circumference to grooves 652 of theneedles 650, and are sufficiently resilient to expand in circumferencein response to the downward force of the needles 650, so as to slideover the conical tip 654.

In one embodiment, the looped end 41 comprises an eyelet that is formedas a unitary, integral part of the suture 40. The suture eyeletcomprises a flat, thin portion of suture material having a centralopening that is slightly smaller than the base of the tip 654. Theperiphery of the disc is contoured to match that of the recess 632 ofthe clasp arms. The disc is sized to fit within the recess and to beretained therein by interference fit. The looped end 41 of the suture 40may be formed by heating one end of a length of suture such as by astream of hot gas until the end becomes a ball-shape and pliable. Theball-shaped end is then deformed by compressing it into a disc shapewhile the suture material is still pliable. A sharpened hypotube is thenused to punch out the hole near the center of the disc-shaped end suchthat the disc-shaped end forms the eyelet. If desired, the disk may bebent relative to the strand while the material is pliable to put apermanent set in the bent suture. In one configuration, the suturecomprises a monofilament or plastic suture material, such as prolene ordeclene. In one method of forming the looped end, instead of heating theend of a suture length, the suture end is simply compressed and a holeis formed thereafter. The end may be further cut or stamped into acircle shape.

In another configuration, instead of pre-forming the hole in the sutureend, the actuation of the needles 650, as described below with referenceto FIG. 56, is used to form the hole and fasten the ends of the sutureto the needles 650.

In another configuration, a separately-formed loop is insert-molded,glued, crimped or otherwise attached to the end of a length of suture.The loop may be in the shape of a circle, oval, triangle, rectangle,hexagon, octagon, etc.

The general use and operation of the suture clasp arms 630, 630′ inFIGS. 52A-56 is substantially similar to the use and operation of thesuture clasp arms 524 described above with reference to FIGS. 41-48.Specifically, the looped ends 41 of the suture 40 are placed within theannular recess 632 of the suture clasp arms 630, 630′ (FIGS. 52A and54). The suture introducer head 522 is inserted into biological tissue(similar to FIG. 47), and the suture clasp arms 630, 630′ are deployedradially outward (FIG. 55). The penetrating flexible needles 650 passthrough the biological tissue to be sutured (similar to FIG. 47) andengage the suture clasp arms 630, 630′ (FIG. 56).

When the needle points 654 pass through the looped ends 41 of the suture40, the looped ends 41 elastically stretch slightly, so as tocircumferentially flex momentarily. As the needles 650 continue toadvance distally, the looped ends 41 relax, fall into the grooves 652,and fasten around the needle grooves 652, such that pulling the needles650 proximally causes the suture ends 41 to follow the proximal movementof the needles 650. Thus, the grooves 652 provide the same generalfunction as the suture catches 38 (FIG. 41) described above withreference to FIGS. 41-42 and 47. In an alternative embodiment, theneedles are formed without a groove or shoulder, and the shaft of theneedle is sized relative to the opening in the eyelet to provide aninterference fit therebetween.

FIGS. 58-59 are perspective views of a suturing device 660 with afour-arm suture clasp member used with the device of FIG. 1C-1D. Thesuturing device 660 shown in FIGS. 58-59 comprises four needle apertures670 and four suture clasp arms 662-668. Each of the four suture clasparms 662-668 comprises an annular recess and a slit for the length ofthe suture. In one embodiment, two sutures are used with the deviceshown in FIGS. 58-69, each of which is held by a pair of suture clasparms. Each suture has a loop at either end which is placed within one ofannular recesses of a suture clasp arm. The arms 662-668 mayalternatively be provided with one of the other types of suture claspstructures disclosed herein.

FIG. 60 is a perspective, exploded view of another handle configuration700 attached to the proximal end of the device of FIG. 41, the device ofFIG. 48 or the device of FIG. 52A. FIG. 61 is a perspective view of thehandle of FIG. 60. In FIG. 60, the handle 700 comprises a thumb ring702, a plunger 704, a plunger distal end 706, a main housing 710, aproximal aperture 708, a finger ring 712, a sloped floater peg slot 714,a floater clamp slot 715, a distal end aperture 716, a floater 720, apeg 718, a floater clamp lock 722, a floater clamp 724, a drive wire(actuating rod 50) clamp 726, a needle holder backer 728, a needleholder 730, a floater clamp peg 732, a floater clamp aperture 734, aspring 736, at least one plunger peg 738, L-shaped lock recess 740 andan extrusion (hollow elongated body 514) clamp 742.

The spring 736, the floater 720, the floater clamp lock 722, the floaterclamp 724, the drive wire clamp 726, the needle holder backer 728, theneedle holder 730 and the extrusion clamp 732 are operatively receivedwithin the main housing 710. The shaft of the plunger 704 is slidablyreceived through the floater 720, the floater clamp lock 722 and thefloater clamp 724.

The square- or rectangular-shaped shaft of the plunger 704 fits withinthe square- or rectangular-shaped axial recess of the floater 720, suchthat rotating the plunger 704 clockwise causes the floater 720 to rotateclockwise as well. The plunger distal end 706 is adapted to snap into orotherwise attach itself into the needle holder backer 728. The plungerpegs 738 are slidably received along the L-shaped lock recess 740 formedon the interior of the main housing 710.

In a preferred configuration, the L-shaped recess lock 740, the floaterpeg slot 714 and the floater clamp slot 715 are all molded, carved orotherwise formed on the interior of the main housing 710. The spring 736provides a proximal biasing force on the plunger pegs 738 and theplunger 704. The spring 736 also provides a distal biasing force on thefloater 720.

The floater peg 718 is slidably received along the sloping floater pegslot 714. The distal end of the floater 720 snaps and locks into theproximal portion of the floater clamp lock 722. The floater clamp lock722 is preferably glued, bonded or otherwise attached to the floaterclamp 724. The drive wire clamp 726 fits within the aperture 734 of thefloater clamp 724. The drive wire clamp 726 is glued, bonded orotherwise attached to a proximal portion of a drive wire or theactuating rod 50 of FIG. 52B.

The extrusion (hollow elongated body 514) clamp 742 is glued, bonded orotherwise attached to a proximal portion of the hollow elongated body514 of FIG. 52A. The needle holder 730 is preferably glued, bonded orotherwise attached to the needle holder backer 728. The proximal portionof the needles 546 of FIG. 47 or the needles 650 of FIG. 55 arepreferably glued, bonded, molded into or otherwise attached to theneedle holder 730.

The use and operation of the handle 700 will now be described withreference to FIG. 60. While the handle 700 is in its initial state andshipped to end-users, the plunger pegs 738 within the L-shaped lockrecess 740 prevent the plunger 704 from moving distally relative to themain housing 710. When a physician rotates the plunger 704 clockwise bytwisting the thumb ring 702, the plunger pegs 738 move circumferentiallyalong the L-shaped lock recess until the plunger pegs 738 are positionedto slide distally down the longitudinal part of the L-shaped lock recess740.

As the physician rotates the plunger 704, the floater 720 also rotatesclockwise. The peg 718 moving within the sloped floater peg slot 714causes the floater 720 to move proximally. Because the drive wire clamp726 is attached to the drive wire or actuating rod 50 (FIG. 52A), theproximal movement of the floater 720 causes the floater clamp lock 722,the floater clamp 724, the drive wire clamp 726, and the actuating rod50 to move proximally, such that the suture clasp arms 630, 630′ deployradially outward (FIG. 52A-52B).

Once the plunger 704 is fully rotated and the plunger pegs 738 arepositioned to slide distally down the longitudinal part of the L-shapedlock recess 740, the physician may advance the plunger 704 distally. Thedistal movement of the plunger 704 causes the needles 546 (FIG. 47) orthe needles 650 (FIG. 55) to advance distally, penetrate the biologicaltissue, and engage the suture clasp arms 524, 630, 630′ (FIG. 47 andFIG. 55).

One of the advantages of the handle 700 is that the L-shaped lock recess740 prevents the plunger 704 and the needles 546 (FIG. 47) or theneedles 650 (FIG. 55) from advancing prematurely. This preventsunintentional deployment of the needles 546, 650 which may cause damageto the patient's tissues 14, 22 (FIG. 1D).

Six-Arm and Eight-Arm Embodiments

FIGS. 62-65 illustrate another suture device configuration 750. FIG. 62is a perspective view of the suture device 750 with six suture clasparms 756-766 (only three of which are visible in FIG. 62). FIG. 63 is aperspective view of the device 750 of FIG. 62 with the suture clasp arms756-766 fully deployed. FIG. 64 is a perspective view from the distalend of the device 750 of the six suture clasp arms 756-766 of FIG. 62.FIG. 65 is a perspective view of the device of FIG. 62 with the sutureclasp arms fully deployed and a set of needles engaging the suture clasparms.

In FIG. 62, the structure of the suture introducer head 752 issubstantially similar to the suture introducer head 522 of FIG. 52A,except the suture introducer head 752 in FIG. 62 comprises six suturearm apertures 508 and six needle apertures 510. Similarly, the structureof the hollow elongated body 754 in FIG. 62 is substantially similar tothe structure of the hollow elongated body 514 in FIG. 52A, except thehollow elongated body 754 in FIG. 62 comprises six needle lumens (notshown) to house the needles 650. Alternatively, the hollow elongatedbody 754 and the suture introducer head 752 may be one integrated piece,similar to the device 515 in FIG. 48.

In another embodiment, the suture device may have eight suture clasparms, eight suture clasp arm apertures, eight needles, eight needleapertures, eight needle lumens and four sutures.

In a preferred embodiment, there is a handle (not shown) at the proximalend of the suture device 750 which allows a physician to operate thesuture device 750. The handle may be similar to any one of the handleembodiments described above and below, except that the handle for suturedevice 750 is adapted to operate six suture clasp arms and six needles.

The structure of the suture clasp arms 756-766 of FIG. 62 issubstantially similar to the structure of the suture clasp arm 630′ inFIG. 53B. Alternatively, the structure of the suture clasp arms 756-766is substantially similar to the suture clasp arm 630 (with a curvedportion 638) in FIG. 53A. As shown in FIG. 63, each suture clasp arm756-766 comprises an annular recess 632 for holding a looped end 41 of asuture 40. As shown in FIG. 64, each suture clasp arm 756-766 comprisesa hinge portion 636, which is similar to the hinge portion 636 shown inFIG. 53B.

In FIG. 64, the suture introducer head 752 comprises a center ring 770with six spokes 772. Each hinge portion 636 is operatively attached to aspoke 772 by a pivot pin (not shown), which is substantially similar instructure and function to the pivot pin 502 in FIG. 52B. The center ring770 is attached to an actuating rod (not shown), which is substantiallysimilar in structure and function to the actuating rod 50 in FIG. 52B.

In addition, the structure of the suture 40 and the needles 650 in FIG.62 is substantially similar to the structure of the suture 40 and theneedles 650 in FIG. 52A. In FIG. 62, there are six needles 650 and threesutures 40. Each suture 40 has a loop 41 at each end of the suture 40.

The general use and operation of the suture device 750 in FIGS. 62-65 issubstantially similar to the use and operation of the suture devicesdescribed above with reference to FIG. 41-48 and FIGS. 52A-56.Specifically, in FIG. 63, a first looped end 41 of a first suture 40 isplaced within the annular recess 632 of a first suture clasp arm 756,and the second looped end 41 of the same suture 40 is placed within theannular recess 632 of a second suture clasp arm 762. The second sutureclasp arm 762 is on the opposite side (180 degrees) of the sutureintroducer head 752 in relation to the first suture clasp arm 756.Similarly, a first looped end 41 of a second suture 40 is placed withinthe annular recess 632 of a third suture clasp arm 766, and the otherlooped end 41 of the second suture 40 is placed within the annularrecess 632 of a fourth suture clasp arm 760. The third suture clasp arm766 is on the opposite side (180 degrees) of the suture introducer head752 in relation to the fourth suture clasp arm 760. Lastly, a firstlooped end 41 of a third suture 40 is placed within the annular recess632 of a fifth suture clasp arm 758, and the other looped end 41 of thethird suture 40 is placed within the annular recess 632 of a sixthsuture clasp arm 764 (FIG. 64).

To assist a user in placing the six suture loops 41 properly, the sutureclasp arms 756-766 may be colored to distinguish each suture clasp armpair. For example, suture clasp arms 756 and 762 may be colored red,suture clasp arms 760, 764 may be colored white, and suture clasp arms758 and 766 may be colored blue. Alternatively, instead of colors, thesuture clasp arm pairs may have another type of indication, such as amarking. Alternatively, the suture introducer head 752 or the elongatedbody 754 may include an indication, such as coloring or markings toindicate the suture clasp arm pairs.

In operation, the suture introducer head 752 of FIG. 62 is inserted intobiological tissue 22 (similar to FIG. 47). The physician preferably usesa handle to deploy the six suture clasp arms 756-766 radially outward(FIG. 63). The physician uses the handle to advance the six penetratingflexible needles 650 through the biological tissue 22 to be sutured(similar to FIG. 47) and to engage the suture clasp arms 756-766 (FIG.56) simultaneously. Alternatively, in another method, the three pairs ofneedles 650 advance distally through the tissue 22 and engage the sutureclasp arms 756-766 at different times.

When the needles 650 engage the suture clasp arms 756-766, the needles650 capture the ends 41 of the sutures 40. The needles 650 are thenwithdraw proximally with the ends 41 of the sutures 40 attached. Oncethe needles 650 are drawn into the needle apertures 510, the combinationof the circular detents or grooves of the needles 650 and the insidesurface of the suture introducer head 752 securely holds the sutures 40or creates a lock on the sutures 40 such that withdrawing the suturedevice 750 will not cause the suture ends 41 to slip out of theapertures 510.

After the needles 650 pull the ends 41 of the three sutures 40proximally out of the tissue 22, the physician removes the suture device750 from the patient's tissues 22, 14 (FIG. 1B). The physician thenreleases the suture ends 41 from the needles 650 and ties three knots tosecure the three sutures 40 at the suture site 26 (FIG. 1B).

Compact, Four-Arm Embodiment

FIGS. 66-69 illustrate another suture device configuration 800 of thepresent invention. FIG. 66 is a perspective view from the distal end ofthe suture device 800 with four suture clasp arms 804-810. FIG. 67 is aperspective view of the suture device 800 of FIG. 66 with the sutureclasp arms 804-810 fully retracted. FIG. 68 is a perspective view of thesuture device 800 of FIG. 66 with the suture clasp arms 804-810partially deployed. FIG. 69 is a perspective view of the suture device800 of FIG. 66 with the suture clasp arms 804-810 fully deployed and aset of needles 650.

In FIG. 66, the structure of the suture introducer head 801 issubstantially similar to the suture introducer head 522 of FIG. 52A,except the suture introducer head 801 of FIG. 66 has four suture clasparm apertures 508, four needle apertures and four needle guides 802.Similarly, the structure of the hollow elongated body 870 attached toproximal end of the suture introducer head 801 of FIG. 66 issubstantially similar to the elongated body 514 of FIG. 52A, except theelongated body 870 attached to the suture introducer head 801 has fourneedle lumens (not shown). Alternatively, the hollow elongated body 870and the suture introducer head 801 may be one integrated piece, similarto the device 515 in FIG. 48.

In a preferred embodiment, there is a handle (not shown) at the proximalend of the suture device 800 which allows a physician to operate thesuture device 800. The handle may be similar to any one of the handleembodiments described above and below, except that the handle for suturedevice 800 is adapted to operate four suture clasp arms and fourneedles.

Like the suture clasp arm 630 in FIG. 52A, the suture clasp arms 804-810of FIGS. 66-69 comprise hinge portions 820-826, apertures for pivot pins(e.g., an aperture 846 and a pivot pin 842 are shown in FIG. 69),annular recesses for holding looped ends of a suture 40 (e.g., anannular recess 844 is shown in FIG. 68), sloped ends 848-854 forfacilitating deployment of the suture clasp arms 804-810, and slits856-862 for the lengths of sutures 40.

The suture clasp arms 804-810 further comprise sloped side surfaces812-818 and curved recesses 828-834. The sloped side surfaces 812-818facilitate deployment and/or retraction of the suture clasp arms 804-810when the sloped side surfaces 812-818 come in contact with the edges ofthe suture clasp arm apertures 508. The curved recesses 828-834 areconfigured to accommodate the hinge portions 820-826 of the suture clasparms 804-810. For example, the curved recess 828 accommodates the hingeportion 826 and provides sufficient space for both suture clasp arms804, 810 to deploy and retract without hindering each other.

In FIG. 66, the suture device 800 comprises a central hinge member 836which is attached to an actuating rod (not shown, but similar to theactuating rod 50 in FIG. 52B) via an actuating rod aperture 838. Thecenter hinge member 836 comprises four pivot pins, such as the pin 848shown in FIG. 69. The hinge portions 820-826 of the suture clasp arms804-810 rotate or pivot about the pivot pins. From a perspective view,such as FIG. 66, the suture clasp arms 804-810 and the central hingemember 836 resemble a pin-wheel.

The suture device 800 further comprises a spreader 840 (FIGS. 67-69).The structure of the spreader 840 is slightly different than thespreader 523 in FIGS. 43D and 52A, but the function is the same. Likethe spreader 523 described above with reference to FIGS. 43D and 52A,the distal end of the spreader 840 in FIG. 67 is configured to spreadthe four suture clasp arms 804-810 into their deployed position when thecentral hinge member 836 is moved proximally.

The general use of the suture device 800 in FIGS. 66-69 is substantiallysimilar to the use and operation of the suture devices described abovewith reference to FIGS. 41-48, 52A-56 and 62-65. Specifically, a firstlooped end 41 of a first suture 40 is placed within the annular recessof a first suture clasp arm 804, and the second looped end 41 of thesame suture 40 is placed within the annular recess of a second sutureclasp arm 808. The second suture clasp arm 808 is on the opposite side(180 degrees) of the suture introducer head 801 in relation to the firstsuture clasp arm 804. Similarly, a first looped end 41 of a secondsuture 40 is placed within the annular recess of a third suture clasparm 806, and the other looped end 41 of the second suture 40 is placedwithin the annular recess of a fourth suture clasp arm 810. The thirdsuture clasp arm 806 is on the opposite side (180 degrees) of the sutureintroducer head 801 in relation to the fourth suture clasp arm 810.

As shown in FIG. 66, the suture clasp arms 804-810 do not deploy andretract in the same manner as the four suture clasp arms 660-668 of thesuturing device 660 shown in FIG. 59 (and other suturing devicesdisclosed herein, such as the suturing device 520 shown in FIG. 41 andthe suturing device shown in FIG. 52A). In FIG. 59, each suture clasparm 660-668 (and a needle associated with each suture clasp arm 660-668)deploys and retracts within a two-dimensional plane, and the centrallongitudinal axis of the suturing device 660 lies within each plane.

By comparison, in FIG. 66, the suture clasp arms 804-810 deploy andretract off-center in relation to the central longitudinal axis of thesuture device 800. In other words, each suture clasp arm 804-810 (and aneedle 650 (FIG. 69) associated with each suture clasp arm 804-810)deploys and retracts within a two-dimensional plane, and the centrallongitudinal axis of the suturing device 800 is offset or displaced fromeach plane. The plane associated with a first suture clasp arm 804 ispreferably parallel to the plane associated with a second suture clasparm 808. Likewise, the plane associated with a third suture clasp arm806 is preferably parallel to the plane associated with a fourth sutureclasp arm 810. All of these planes are preferably parallel to thelongitudinal axis.

This pin-wheel configuration of the suture clasp arms 804-810 shown inFIG. 66 allows the suture device 800 to be built compactly with arelatively small diameter. In one embodiment, the suture device 800 issized to fit an 8 french catheter or tube. Alternatively, in otherembodiments, the suture device 800 may be sized to fit a catheter ortube that is smaller than or larger than 8 french.

In another embodiment of the suturing device 800, the centrallongitudinal axis is angularly offset from at least one of the fourplanes such that the central longitudinal axis intersects at least oneof the four planes.

In another embodiment, the plane associated with a first suture clasparm 804 intersects the plane associated with a second suture clasp arm808. In addition, the plane associated with a third suture clasp arm 806may intersect the plane associated with a fourth suture clasp arm 810.

The needle guides 802 shown in FIG. 69 preferably direct the tips of theneedles 650 such that they deploy distally and retract proximally alonga path that is curved in three dimensional space and which is offsetfrom the central longitudinal axis of the suture device 800. In effect,the needletips move both sideways and outwardly relative to the centralaxis. Stated another way, if the needle tips in their retreated positionlie in respective planes in which the central longitudinal axis alsolies, then the path of these needle tips will diverge from the planes asthe tips move from their retracted position to their extended position.

Alternatively, in another embodiment, each suture clasp arm 804-810(FIG. 66) deploys and retracts within a two-dimensional plane which isoffset from the central longitudinal axis of the suture device 800, buteach needle 850 deploys distally and retracts proximally in a twodimensional plane.

Alternatively, in another embodiment, each needle 850 (FIG. 69) deploysdistally and retracts proximally within a two-dimensional plane which isoffset from the central longitudinal axis of the suture device 800, buteach suture clasp arm 804-810 deploys distally and retracts proximallyin an arc or curve.

Alternatively, in other embodiments, this pin-wheel configuration (wherethe central longitudinal axis of the suturing device 800 is offset fromeach plane associated with a suture clasp arm 804-810) and the relatedvariations described above are embodied in suturing devices with lessthan or greater than four suture clasp arms, such as two, six or eightsuture clasp arms.

In operation, the suture introducer head 802 of FIG. 66 is inserted intobiological tissue with the suture arms 804-810 withdrawn, as shown inFIG. 67 (similar to FIG. 47). The physician preferably uses a handle todeploy the four suture clasp arms 804-810 radially outward, as shown inFIGS. 68 and 69. The physician uses the handle to advance the fourpenetrating flexible needles 650 through the biological tissue to besutured (similar to FIG. 47) and to engage the suture clasp arms 804-810(FIG. 69) simultaneously. Alternatively, in another method, the twopairs of needles 650 advance distally through the tissue and engage thesuture clasp arms 804-810 at different times.

Once the needles 650 pull the ends 41 of the two sutures 40 proximallyout of the tissue 22, the physician ties two knots to secure the twosutures 40.

Movable Sheath

FIGS. 70-71 illustrate a movable sheath 872 that may be used with thesuture devices described above. For purposes of illustration, the sheath872 is shown in FIGS. 70-71 in use with the suture device 800 of FIG.67. Alternatively, the sheath 872 may be adapted for use with any of thesuture devices described above with reference to FIGS. 1A-69.

In FIG. 70, the sheath 872 comprises a thin-wail catheter which coversthe entire suture device 800 or at least a distal portion of the suturedevice 800. In one configuration, the sheath 872 includes an opening atits distal end. In another configuration, the sheath 872 does notinclude an opening at its distal end, but may have a perforation whichcan be torn by downward pressure of the suture device 800 to create anopening. The sheath 872 is preferably formed or placed on the suturedevice 800 during manufacturing. In one configuration, the sheath 872comprises polyimide. Alternatively, other materials may be used insteadof or in addition to polyimide.

One of the advantages to the sheath 872 is that it protects the exposedportions of the sutures 40 from premature displacement as the suturedevice 800 is inserted distally through the CSI 6, the patient's tissue14 and the vessel 22. The sheath 872 may also protect other exteriorparts of the suturing device 800 and/or the tissue 14 and incision 26(FIG. 70). In one embodiment, the sheath 872 also protects the exposedportions of the sutures 40 as the suture device 800 is withdrawnproximally through the CSI 6, the patient's tissue 14 and the vessel 22.

In operation, after the suture device 800 is inserted through the CSI 6,the patient's tissue 14 and the vessel 22, the user removes the sheath872 at least partially from the suture introducer head 801. This isshown in FIGS. 70-71. There may be a number of ways to remove the sheath872. In one embodiment, the user manually removes the sheath 872 bysliding it proximally along the suture device 800. In anotherembodiment, the plunger 704 of the handle 700 in FIG. 60 is attached tothe sheath 872, such that rotating the plunger 704 causes the sheath 872to slide proximally.

In addition, in one embodiment, the sheath 872 may be advanced distallyover the suture introducer head 801 after the needles 650 have capturedthe ends 41 of the sutures 40 and retracted into the needle lumens. Inthis manner, the sheath 872 protects the exposed portions of the sutures40 as the suture device 800 is withdrawn proximally through the CSI 6,the patient's tissue 14 and the vessel 22.

Occlusion Devices

FIGS. 72-73 illustrate occlusion devices 880, 890 that may be used withthe suture devices described above to temporarily occlude the incision26 and minimize the amount of blood escaping from the blood vessel 16through the incision 26. The occlusion devices 880, 890 are preferablyadapted to allow blood to flow through the blood vessel 16 itselfuninterrupted. Alternatively, in another embodiment, the occlusiondevices 880, 890 are adapted to occlude the entire blood vessel 16,including the incision 26.

For purposes of illustration, the occlusion devices 880, 890 are shownin FIGS. 72-73 in use with the suture device of FIG. 52A. Alternatively,the occlusion devices 880, 890 may be adapted for use with any of thesuture devices described above with reference to FIGS. 1A-69.

In FIG. 72, the occlusion device comprises a balloon 880 which isadapted to temporarily occlude the incision 26 to be sutured. Theballoon 880 may comprise polyethylene, polyurethane, other polymers orany other material with similar properties. The balloon 880 is attachedto a hollow tube 882 which is attached to a lumen (not shown) within thesuture introducer head 522 and the hollow elongated body 514.Alternatively, the hollow tube 882 may extend through the lumen withinthe suture introducer head 522 and the hollow elongated body 514, andmay slide within such lumen. The hollow tube 882 may be flexible orsubstantially rigid. The hollow tube 882 is used to inflate the balloon880. The balloon 882 may be inflated with saline solution or any fluidthat is safe for internal occlusion devices.

In operation, inflation of the balloon 880 is initiated after (1) theneedles capture the ends of the suture 40 from the suture clasp arms630, 630′ and (2) the suture clasp arms 630, 630′ are retracted into thesuture introducer head 522. This is shown in FIG. 72. The balloon 880temporarily occludes the incision 26 while the suture introducer head522 is being withdrawn proximally from the tissue 14 and the physicianis tying a knot with the suture ends. The physician slides the knotdistally toward the incision 26. Before the physician tightens the knot,the physician deflates the balloon 880 and withdraws the balloon 880from the vessel 16 and the tissue 14. Finally, the physician thentightens the knot to close the incision 26.

In FIG. 73, the occlusion device comprises an inverting member 890, suchas the inverting members shown and described in U.S. Pat. No. 5,944,730entitled “DEVICE AND METHOD FOR ASSISTING END-TO-SIDE ANASTOMOSIS” filedon Mar. 6, 1997, the entirety of which is incorporated by referenceherein. The inverting member 890 is attached to an actuator 892 whichextends through a lumen (not shown) within the suture introducer head522 and the hollow elongated body 514. As described in theabove-referenced patent, the inverting member 890 comprises: anelongated shaft or tube and an expandable inverting member which forms acup or umbrella-like structure that can be used to form a sealed pocketagainst the inner wall 22 of the vessel 16.

Like the occlusion balloon 880 described above with reference to FIG.72, the inverting member 890 is adapted to temporarily occlude theincision 26 to be sutured. In operation, the inverting member 890protrudes from the distal tip of the suture introducer head 522. Theinverting member 890 is expanded from a collapsed configuration to anexpanded configuration after (1) the needles capture the ends of thesuture 40 from the suture clasp arms 630, 630′ and (2) the suture clasparms 630, 630′ are retracted into the suture introducer head 522. Thisis shown in FIG. 73. The inverting member 890 temporarily occludes theincision 26 while the suture introducer head 522 is being withdrawnproximally from the tissue 14 and the physician is tying a knot with thesuture ends. The physician slides the knot distally toward the incision26. Before the physician tightens the knot, the physician collapses theinverting member 890 so that the expanded cup is contracted against theshaft, and withdraws the inverting member 890 from the vessel 16 and thetissue 14. Finally, the physician then tightens the knot to close theincision 26.

Alternate Handle Embodiment

FIG. 74A is a perspective view of another embodiment of a handle 900capable of being attached to the proximal end of the device of FIG. 41,the device of FIG. 48 or the device of FIG. 52A. Similarly, FIG. 74B isa perspective view of another embodiment of a handle 900 adapted toseparately actuate the first and second needles. A portion of the mainhousing 910 has been removed in FIGS. 74A and 74B to expose theinterior. FIGS. 75A and 75B are exploded, perspective views of theembodiment shown in FIG. 74A. FIG. 76A is an exploded, perspective viewof the embodiment shown in FIG. 74B, and FIGS. 76B-D schematicallyillustrate various embodiments of the needle drivers adapted toseparately actuate the first and second needles. FIGS. 74B and 76A-Dwill be described more fully below in connection with thenon-simultaneous actuation of the first and second needles.

In FIGS. 74A, 75A, and 75B, the handle 900 comprises a thumb ring 902, aplunger 904, a plunger distal end 906, a main housing 910, a proximalaperture 908, a finger ring 912, a sloped floater peg slot 914, afloater clamp slot 915, a distal end aperture 916, a floater 920, a peg918, a floater clamp lock 922, a pair of finger grips 924, a pair ofneedle holding apertures 926, a rotator 930, a 928 rotator grip, adistal portion 932 of the rotator 930, a central lumen 934 in therotator 930, a spring 936, at least one plunger peg 938, and an L-shapedlock recess 940.

In a preferred embodiment, the handle 900 further comprises othermembers which are substantially similar to the members of the handle 700described above with reference to FIGS. 60 and 61. These members includea floater clamp (not shown), a drive wire clamp for an actuating rod 50(e.g., FIG. 52B), a floater clamp peg, a floater clamp aperture, and anextrusion clamp for a hollow elongated body 514 (e.g., FIG. 52B).

As shown in FIG. 74A, at least a portion of the spring 936, the plunger904, the rotator 930, the floater 920, the floater clamp lock 922, thefloater clamp (not shown), the drive wire clamp (not shown), and theextrusion clamp (not shown) are operatively received within the mainhousing 910, similar to FIG. 60. The distal portion 906 of the plunger904 is slidably received through the rotator 930, the floater 920, thefloater clamp lock 922 and the floater clamp (not shown), similar toFIG. 60.

The square- or rectangular-shaped distal portion 932 of the rotator 930fits within the square- or rectangular-shaped axial recess of thefloater 920, such that rotating the rotator 930 clockwise causes thefloater 920 to rotate clockwise as well. The plunger pegs 938 areslidably received along the L-shaped lock recess 940 formed on theinterior of the main housing 910.

In a preferred configuration, the L-shaped recess lock 940, the floaterpeg slot 914 and the floater clamp slot 915 are all molded, carved orotherwise formed on the interior of the main housing 910. The spring 936provides a proximal biasing force on the plunger peg 938 and the plunger904. The spring 936 also provides a distal biasing force on the floater920.

The floater peg 918 is slidably received along the sloping floater pegslot 914. The distal end of the floater 920 snaps and locks into theproximal portion of the floater clamp lock 922. The floater clamp lock922 is preferably glued, bonded or otherwise attached to the floaterclamp, similar the one shown in FIG. 60. Similar to the handle 700 ofFIG. 60, the drive wire clamp fits within the aperture of the floaterclamp. The drive wire clamp (not shown) is glued, bonded or otherwiseattached to a proximal portion of a drive wire or an actuating rod 50(e.g., FIG. 52B).

The extrusion clamp (not shown) is glued, bonded or otherwise attachedto a proximal portion of a hollow elongated body 514 (e.g., FIG. 52A).The proximal portion of the needles 546 of FIG. 47 or the needles 650 ofFIG. 55 are preferably glued, bonded, molded into or otherwise attachedto the needle holding apertures 926 of the plunger 904.

The use and operation of the handle 900 will now be described withreference to FIGS. 74A, 75A, and 75B. While the handle 900 is in itsinitial state and shipped to end-users, the plunger pegs 938 within theL-shaped lock recess 940 prevent the plunger 904 from moving distallyrelative to the main housing 910. When a physician rotates the rotator930 clockwise by twisting the rotator grip 928, the plunger pegs 938move circumferentially along the L-shaped lock recess 940 until theplunger pegs 938 are positioned to slide distally down the longitudinalpart of the L-shaped lock recess 940.

As the physician rotates the rotator 930, the floater 920 also rotatesclockwise. The peg 918 moving within the sloped floater peg slot 914causes the floater 920 to move proximally. Because the drive wire clampis attached to the drive wire or actuating rod 50 (e.g., FIG. 52A), theproximal movement of the floater 920 causes the floater clamp lock 922,the floater clamp, the drive wire clamp, and the actuating rod 50 tomove proximally, such that the suture clasp arms 630, 630′ deployradially outward (FIG. 52A-52B). As shown in FIG. 75B, the proximal sideof the rotator grip 928 preferably has a marking 842 which indicates thedirection of rotation (e.g., clockwise) required to deploy the sutureclasp arms 630, 630′.

Full rotation of the rotator 930 disables the lock so as to allow theplunger 902 to move longitudinally relative to the main housing 910.When the rotator 930 is fully rotated, the plunger pegs 938 arepositioned to slide distally down the longitudinal part of the L-shapedlock recess 940, and the physician may advance the plunger 904 distally.The distal movement of the plunger 904 causes the needles 546 (FIG. 47)or the needles 650 (FIG. 55) to advance distally, penetrate thebiological tissue, and engage the suture clasp arms 524, 630, 630′ (FIG.47 and FIG. 55).

One of the advantages of the handle 900 is that the L-shaped lock recess940 prevents the plunger 904 and the needles 546 (FIG. 47) or theneedles 650 (FIG. 55) from advancing prematurely. This preventsunintentional deployment of the needles 546, 650 which may cause damageto the patient's tissues 14, 22 (FIG. 1D).

Moving Arms and/or Needles at Different Times

In the embodiments described herein, the suturing device may beconfigured to deploy the arms at different times, to deploy the needlesto engage the suture at different times or to deploy one arm and itsassociated or corresponding needle and then deploy another arm and itsassociated or corresponding needle. For example, FIG. 77 illustrates thesuture device of FIG. 56 adapted to move a first needle 650 distally toengage a first suture clasp arm 630 before moving a second needle 650′(FIG. 78) distally to engage a second clasp arm 630′. FIG. 78illustrates the suture device of FIG. 77 with the second needle 650′moving distally to engage the second suture clasp arm 630′. In certainembodiments, the first needle 650 engages the first suture clasp arm 630before the second needle 650′ engages the second suture clasp arm 630′.In other embodiments, the first needle 650 engages the first sutureclasp arm 630 before the second needle 650′ moves distally. In stillother embodiments, the first and second suture clasp arms 630, 630′ aredeployed non-simultaneously. For example, the second suture clasp arm630′ is deployed after the first suture clasp arm 630 is deployed andafter the first needle 650 engages the first suture clasp arm 630.

Likewise, the first and second needles 650, 650′ may be moved proximallyat different times. For example, the first needle 650 may be withdrawnproximally after it captures one end of the suture 40 before the secondneedle 650′ is withdrawn proximally after the second needle 650′captures the other end of the suture 40. In one embodiment, the firstand second needles 650 and 650′ are separably actuatable such that eachneedle is deployed independently of the other needle at different times.Alternatively, in other embodiments, the first and second needles 650and 650′ are deployed by a common actuator adapted to first deploy oneneedle, and then to deploy the other needle.

One embodiment in which the first and second needles 650 and 650′ areseparately actuable such that each needle is deployed independently ofthe other needle at different times is schematically illustrated inFIGS. 74B and 76A. The handle 900 of FIGS. 74B and 76A closely mirrorsthat of FIGS. 74A, 75A, and 75B, but includes a pair of needle drivers905, 905′ each with a thumb ring 903, 903′, a needle driver distal end907, 907′, and a needle holding aperture 927, 927′, respectively. Eachneedle driver 905, 905′ also has a driver peg 939, 939′. The needledrivers 905, 905′ each have a needle (not shown) connected to the needleholding aperture 927, 927′ of its needle driver distal end 907, 907′.The combination of the needle drivers 905, 905′ of the embodiment ofFIGS. 74B and 76A is similar to the plunger 904 of FIGS. 74A, 75A and75B. However, the needle drivers 905, 905′ are adapted to be slidablydisplaced relative to one another and to the handle 900, therebyseparately actuating the two needles 650, 650′.

As shown in FIG. 74B, the needle driver distal ends 907, 907′ of theneedle drivers 905, 905′ are slidably received through the rotator 930,the floater 920, the floater clamp lock 922 and the floater clamp (notshown), similar to the single plunger 704 of the embodiment of FIG. 60and the single plunger 904 of the embodiment of FIG. 74A. The driverpegs 939, 939′ are slidably received along the L-shaped lock recess 940formed on the interior of the main housing 910.

While the handle 900 is in its initial state and shipped to end-users,the driver pegs 939, 939′ within the L-shaped lock recess 940 preventthe needle plungers 905, 905′ from moving distally relative to the mainhousing 910. When a physician rotates the rotator 930 clockwise bytwisting the rotator grip 928, the driver pegs 939, 939′ movecircumferentially along the L-shaped lock recess 940 until the driverpegs 939, 939′ are positioned to slide distally down the longitudinalpart of the L-shaped lock recess 940. In this position, the needledrivers 905, 905′ can be moved longitudinally relative to the mainhousing 910 and relative to each other. The distal movement of theneedle drivers 905, 905′ cause the needles 650, 650′ to advancedistally, penetrate the biological tissue, and engage the suture clasparms 630, 630′ (FIGS. 77 and 78). In this way, the needles 650, 650′ canbe non-simultaneously actuated by individually advancing the needledrivers 905, 905′ at different times. The driver pegs 939, 939′ of theembodiment illustrated in FIGS. 74B and 76A operate in a similar manneras do the plunger pegs 938 described above for the use and operation ofthe embodiment illustrated in FIGS. 74A, 75A, and 75B.

FIGS. 76B-D schematically illustrate various embodiments of the needledrivers 905, 905′. In certain embodiments, the two needle drivers 905,905′ are slidably interlocked with one another along at least a portionof their length. The embodiment illustrated in FIG. 76B has needledrivers 905, 905′ which utilize a interlocking clasp configuration.Other embodiments may utilize tongue-in-groove configurations, oraxially concentric needle drivers 905, 905′. Persons skilled in the artcan select an appropriate interlocking configuration for the needledrivers 905, 905′.

In other embodiments, as schematically illustrated in FIG. 76C, one orboth needle drivers 905, 905′ can have a raised area 909 on the surfacewhich is in proximity to the other needle driver. Such a raised area909, 909′ can serve to reduce the sliding friction between the twoneedle drivers 905, 905′, thereby facilitating the independent actuationof the needle drivers 905, 905′. While the raised areas 909, 909′illustrated in FIG. 76C extends along the surface of the needle driverin the axial direction, other embodiments can utilize raised bumps onthis surface. Persons skilled in the art can select an appropriateraised area 909, 909′ for the needle drivers 905, 905′.

In other embodiments, each needle driver 905, 905′ is configured to havea needle holder 911, 911′ which is separately manufactured from theremaining portion of the needle driver 905, 905′. As schematicallyillustrated in FIG. 76D, each needle driver distal end 907, 907′includes a recess 913 which is configured to mate and lock with a flange917, 917′ of the needle holder 911, 911′. In this way, the needleholders 911, 911′ can be fixedly attached to needles, and the needledrivers 905, 905′ can be releasably attached to the needle holders 911,911′.

The suturing device of FIGS. 77-78 may be advantageously used to suturetwo biological tissue portions that are not proximal to one another, asshown in FIGS. 79-81. FIG. 79 illustrates the suture device of FIG. 77with the first needle 650 penetrating a first surface of a firstbiological tissue structure or portion 952 and advancing through asecond surface of the tissue portion 952. The distal end portion of theneedle 650 is circumferentially surrounded by the suture material (endportion of the suture 40) held by the first suture clasp arm 630.

As described herein, the end portion of the suture 40 may be, forexample, a loop with an opening or some other molded shape with orwithout an opening. In one embodiment, the opening formed in the endportion of the suture 40 has a diameter that is approximately the sameas the diameter of the distal end portion of the needle 650. In anotherembodiment, the opening formed in the end portion of the suture 40 has adiameter that is smaller than the diameter of the distal end portion ofthe needle 650

As described above, the needle 650 captures the end of the suture 40lying within the suture clasp arm 630. The needle 650 then movesproximally into the suture introducer head 522 and withdraws the end ofthe suture 40 from the second surface and the first surface of the firsttissue portion 952 and into the suture introducer head 522.

FIG. 80 illustrates the suture device of FIG. 77 with the second needle650′ piercing a second biological tissue portion 950 and engaging thesecond suture clasp arm 630′. The needle 650′ captures the end of thesuture 40 lying within the suture clasp arm 630′ and withdraws the endof the suture 40 into the suture introducer head 522 as the needle 650′moves proximally into the suture introducer head 522.

FIG. 81 illustrates the first and second biological tissue portions 950,952 being drawn together by a suture inserted by the suture device ofFIG. 77. A knot or clip may be slid down the suture 40 to secure thesuture site. In another embodiment, the suture ends may be melted nearthe suture site to secure the suture site.

The four-, six- and eight-arm suture device embodiments described hereinmay also be configured to move each needle at different times. In someembodiments, the needles may be configured to move two or more at atime.

In the embodiments described above, the needles may be drawn proximallyall the way until they are completely removed from the hollow tubularbody 514 while the suture introducer head 522 is still proximal to thesuture site.

Patch

In the embodiments described herein, the suturing devices may be usedwith a patch to facilitate closure, for example, of a surgical site, orother opening, including natural openings that are the result of acongenital defect, such as cardiac septal defects. For example, FIG. 82Aillustrates the suture device of FIG. 77 with a patch 954. The patch 954may comprise a flexible synthetic material, such as, for example, Gortexor Dacron, or a harvested piece of natural tissue. In one embodiment,the patch 954 is preloaded within the suture introducer head 522,threaded onto the suture 40, and deployed from the distal end of thesuture introducer head 522. FIG. 82B illustrates the patch 954 of FIG.82A occluding the suture site as the ends of the suture 40 are drawnproximally. When the ends of the suture 40 are drawn and a knot or clipis slid down to secure the suture site, the patch 954 provides animproved suture closure site.

Alternatively, as illustrated in FIGS. 83A and 83B, a patch 955 can bepositioned on the proximal side of tissue structures 950, 952 after thesuture 40 has been pulled proximally through tissue structures 950, 952.For example, as described above in conjunction with FIG. 79-80, thesuture 40 extends through both tissue structures 950, 952 and out of thebody, as illustrated in FIG. 83A. The physician can thread the suture 40through corresponding apertures in a patch 955 and then push the patch955 distally along the suture 40. Once the patch 955 is in proximity tothe proximal side of the tissue structures 950, 952, the patch 955 canbe secured to the suture site by drawing the suture 40 and slidingdistally a knot or clip to securely hold the patch 955 in place, asillustrated in FIG. 83B.

The patch may be implemented with the 4, 6, and 8-arm suture deviceembodiments described above. For example, FIG. 84 illustrates a patch958 with two pairs of sutures 40, 40′ through the patch 958. The patch958 of FIG. 84 may be used with the four-arm suture device embodimentsdescribed above with reference to FIGS. 58-59 or FIGS. 66-69.

Steerable or Guidable Portion

In the embodiments described herein, the suturing devices may have asteerable or guidable portion for placing sutures at desired suturesites. The steerable portion is particularly advantageous to placesutures in biological structures that are difficult to suture becausethe biological structures are either deep within a patient's body,substantially apart from one another and/or at an entry angle that isdifficult to access.

FIG. 85 illustrates a suture device with a steerable portion 956, suchas the hollow elongated body 514 as described above with reference toFIGS. 52A-52B. In FIG. 85, the steerable, hollow elongated body 956comprises a movable, guide wire within a lumen of the body 956. Theguidewire may be remotely manipulated by a physician outside of thepatient's body, either by a handle that is similar to the handlesdescribed herein or some other control mechanism.

FIG. 85 illustrates the steerable portion bending to the right and afirst needle 650 piercing a first biological tissue portion 952. FIG. 86illustrates the steerable portion bending to the left and a secondneedle 650 piercing a second biological tissue portion 950. In FIGS.85-86, the guide wire is configured to move the suture introducer head522 in 2-dimensions. In another embodiment, the guide wire is configuredto move the suture introducer head 522 in 3 dimensions.

Methods of Forming Suture Ends

FIGS. 87-102 illustrate methods of forming suture ends of a suture whichmay be used with the suture devices described herein. In FIG. 87, oneembodiment of the suture is a strand 1100 of deformable material that ispreferably monofilament, such as Deklene (from Genzyme), Prolene (fromJohnson & Johnson), or Nylon (from Johnson & Johnson). In oneembodiment, the strand 1100 is advantageously approximately 0.010″ thickand has a length that makes it suitable for use in a suture procedure.The strand 1100 is brought near a stream of hot gas 1120, which may be,in one embodiment, 500° F. air ejected from, for example, nozzles 1130.

In FIG. 88, as the distal end of the strand 1100 is impacted by the gas1120, the distal end melts or is otherwise plastically or thermallydeformed to form a locally deformed region 1140 (such as a globule) thatis broader than the rest of the strand 1100 in at least one dimension(i.e., at least one dimension of the strand 1100 has been increased). Bypushing the distal end of the strand 1100 into the stream of gas 1120(e.g., by about 2 mm), the strand 1100 substantially melts back onitself. Once the deformed region 1140 is formed, the strand 1100 may beremoved from the presence of the hot gas 1120 and allowed to cool. As analternative to using the hot gas 1120, the strand 1100 may be broughtinto contact with a hot metal or other solid material, such as asoldering iron (not shown), whereupon the strand 1100 is deformedsimilar to the strand of FIG. 88.

Next, the deformed region 1140 may be flattened, and a hole or eyelet isformed therein, as illustrated in FIGS. 89-94. Alternatively, thedeformed region 1140 may be formed into a cup-like member as discussedbelow in connection with FIGS. 95-98. FIG. 89 illustrates a die 1200used for flattening the deformed region 1140. The die 1200 has a reliefor recessed portion 1210 for accepting the strand 1100 and the deformedregion 1140, as illustrated in FIG. 90. A block 1250, which preferablyalso has a recessed portion 1252 that mates with the recessed portion1210, may then be placed over the deformed region 1140. The aligning ofthe respective recessed portions 1210 and 1252 is facilitated by aplurality of posts 1254 in the die 1200 which mate with respective holes1256 in the block 1250. Thus, the deformed region 1140 is squeezedbetween the die 1200 and the block 1250, resulting in a flattened distalportion 1260 (FIG. 91) that preferably has a thickness that matches therest of the strand 1100. The edges of flattened distal portion 1260 maythen be trimmed to form a circular, smooth disc portion 1270 (FIG. 92)to reduce the risk of such edges snagging on vessel walls duringsuturing procedures.

As illustrated in FIG. 93, a hole or eyelet 1280 may be formed out ofthe distal end of the strand 1100. A punch (not shown) such as ahypotube may be used to poke through the distal portion 1270, therebyleaving the eyelet 1280 in an eyelet portion 1290 at the distal end ofthe strand 1100. The eyelet 1280 is formed such that a surgical hook orneedle as described above may pass through the eyelet in a suturingprocedure. The eyelet portion 1290 acts as a connector to the hook orneedle, allowing the strand 1100 to be picked up by the hook or needle.The method of forming the eyelet 1280 described herein, including theforming of the deformed region 1140, advantageously results in nosignificant reduction in the mechanical strength of the strand 1100,with the material throughout the strand 1100 (including the material inthe eyelet portion 1290) having substantially uniform mechanicalstrength.

Advantageously, the suture embodiment shown in FIG. 93 has no knots orties formed therein which might increase the profile of the suturestrand 1100 or make it easier for the suture to snag during use. Thisprocess may be advantageously repeated at the proximal end of the strand1100, resulting in eyelets 1280 at both ends of the strand 1100, asillustrated in FIG. 94. The eyelet portion 1290 at one or more of theends of the strand 1100 may be bent (not shown) at an angle with respectto the rest of the strand to facilitate the guiding of a surgical needlethrough the eyelet 1280.

FIGS. 95-102 illustrate another embodiment of forming suture endportions. In FIGS. 95-102, the deformed region 1140 (FIG. 87) may beformed into a cup-like member having a recess therein for receiving aneedle. In FIG. 95, the deformed region 1140 is compressed on its sidesby blocks 1300 which have recessed portions 1310. The blocks 1300squeeze the deformed region 1140 to form a substantially cylindricallyshaped member 1320, as shown in FIG. 96.

One end of the member 1320 may be cut off to form a flat top 1330, whichmay then be punched or bored out with a hypotube 1340 to form a suturethat comprises a cup-like member 1335 having a recess 1350, asillustrated in FIGS. 97-98. In one embodiment, the cup-like member 1335has a height of 0.032″ and an outside diameter of 0.032±0.010.″ Therecess 1350 is advantageously sized to accept a distal end portion 1370of a needle 1360 shown in FIGS. 99-101. The surgical needle 1360 has amain shaft portion connected to the distal end portion 1370. Knurling orbarbs are provided on the distal end portion 1370. In this way, when thesurgical needle is inserted into the member 1320 (see FIG. 101), thesurgical needle digs into the sides of the cup shaped recess and resiststhe tendency to be withdrawn from the member 1320. The outside diameterof the member 1320 and the outside diameter of the shaft portion of thesurgical needle 1360 (i.e. the portion proximal to the barbs) mayadvantageously have substantially the same diameter, so that when theneedle 1360/member 1320 combination (see FIG. 101) is withdrawn from thepatient, the possibility that the needle/member combination will snag ontissue is reduced.

The method of forming the cup-like member 1335 described herein,including the forming of the recess 1350, advantageously results in nosignificant reduction in the mechanical strength of the strand 1100,with the material throughout the strand 1100 (including the material inthe member 1335) having substantially uniform mechanical strength. Noknots or ties are necessary. Both ends of the strand 1100 may be formedwith cup-like members 1335, as illustrated in FIG. 102. The cup-likemember 1335 at one or more of the ends of the strand 1100 may be bent(not shown) at an angle with respect to the rest of the strand tofacilitate the guiding of a surgical needle into the recess 1350.

Suspension of Body Tissue

Independent actuation of the arms can be advantageously used to attachor suspend a biological structure, such as a tissue structure or animplantable material. Examples of such procedures include, but are notlimited to, attaching a first tissue structure to a second tissuestructure, or attaching an implantable material, which can be asynthetic material or natural tissue, to a tissue structure. The tissuestructures used in this method can include bones, ligaments, muscletissue, and body organs. In operation, a suture portion 1410 is pulledthrough a tissue structure 1420 for use as an anchor as illustrated inFIG. 103A. One of the arms 1430 is deployed on one side of the tissuestructure 1420 and the corresponding needle 1440 is extended through thetissue structure 1420 to capture the suture portion 1410.

A second suture portion 1410′ can then be looped around a biologicalstructure 1460. As illustrated in FIG. 103A, the second arm 1430′ isdeployed on one side of the biological structure 1460, and thecorresponding needle 1440′ is extended on the other side of thebiological structure 1460, such that the arm 1430′, the needle 1440′,and the elongated body 1470 encircle the biological structure 1460. Thesecond suture portion 1410′ is retrieved from the arm 1430′ by theneedle 1440′ to form a suture loop around the biological structure 1460.In certain embodiments, the suture portions 1410, 1410′ are pulled andtied together forming a knot, bringing the tissue structure 1420 andbiological structure 1460 together as illustrated in FIG. 103B. Incertain embodiments, rather than piercing the tissue structure 1420, thefirst arm 1430 and needle 1440 can be used to loop a suture portion 1410around the tissue structure 1420.

It will be appreciated that the arms 1430 and 1430′ can be deployed inany preferred sequence, and that needles 1440 and 1440′ can retrieve thesuture portions 1410, 1410′ in any preferred sequence. It will also beappreciated that the arms 1430 and 1430′ can be deployed eithersimultaneously or non-simultaneously, and that the needles 1440 and1440′ can be deployed either simultaneously or non-simultaneously.

The embodiment of FIGS. 103A and 103B may also be used for suspending anorgan from an adjacent tissue structure, such as, for example, in thetreatment of bladder or uterine prolapse. Organ suspension may beaccomplished with this embodiment by positioning an arm and extending aneedle into an organ to retrieve a first end of a suture, moving thesuturing device to traverse a space, and then positioning a second armand extending a second needle around a ligament to loop the second endof the suture around the ligament. By tightening the suture, the organis suspended by using the ligament. In other similar embodiments, otherbiological structures, such as harvested pieces of natural tissue, orsynthetic material structures can be suspended or connected to existingbody tissue.

While embodiments and applications of this invention have been shown anddescribed, it will be apparent to those skilled in the art that variousmodifications are possible without departing from the scope of theinvention. It is, therefore, to be understood that within the scope ofthe appended claims, this invention may be practiced otherwise than asspecifically described.

1. A method of closing a patent foramen ovale having proximal and distalsides, comprising: advancing an elongate body into proximity with apatent foramen ovale, the elongate body carrying at least one needle andat least one arm releasably holding at least one suture portion;positioning the at least one arm of said elongate body adjacent to thedistal side by actuating said at least one arm from a first positionwherein said at least one arm is within said elongate body to a secondposition wherein said at least one arm extends away from said elongatebody; positioning the at least one suture portion adjacent tissuesurrounding the patent foramen ovale on the distal side; moving theneedle from the proximal side through said tissue to the distal side andinto engagement with the at least one suture portion held by the atleast one arm on the distal side, retracting the at least one needlethrough said tissue from the distal side to the proximal side with theat least one suture portion released from the at least one arm andengaged with said at least one needle; advancing a patch along the atleast one suture portion towards said patent foramen ovale; and applyinga knot to the at least one suture portion to secure said patch.
 2. Themethod of claim 1, further comprising pulling said at least one sutureportion tight to close said patent foramen ovale by approximating thesurrounding tissue.
 3. The method of claim 1, wherein the patchcomprises collagen.
 4. The method of claim 1, wherein the patchcomprises Dacron.
 5. A method of closing a patent foramen ovale havingproximal and distal sides, the method comprising: advancing a distal endof an elongate body into proximity with a patent foramen ovale, saidelongate body holding a length of suture having first and second sutureportions; positioning first and second arms of said elongate bodyadjacent to the distal side by actuating said first and second arms froma first position wherein said arms are within said elongate body to asecond position wherein said first and second arms extend away from saidelongate body, said first and second arms releasably holding said firstand second suture portions; deploying first and second needles from saidelongate body through tissue surrounding the patent foramen ovale fromsaid proximal side to said distal side and into engagement with thefirst and second suture portions held by said first and second arms;retracting said first and second needles to release said first andsecond suture portions from said first and second arms and draw saidfirst and second suture portions through the tissue surrounding thepatent foramen ovale from said distal side to said proximal side;advancing a patch along said first and second suture portions towardsaid patent foramen ovale; and applying a knot to said suture to holdsaid patch against said patent foramen ovale.
 6. The method of claim 5,further comprising pulling said suture tight to close said patentforamen ovale by a approximating the surrounding tissue.
 7. The methodof claim 5, wherein the patch comprises collagen.
 8. The method of claim5, wherein the patch comprises Dacron.
 9. The method of claim 5, whereinsaid first and second arms are actuated at the same time.
 10. The methodof claim 9, wherein said first and second needles are deployed at thesame time.
 11. The method of claim 9, wherein said first and secondneedles are deployed at different times.
 12. The method of claim 11wherein said first and second needles are deployed sequentially.
 13. Themethod of claim 5, wherein said first and second arms are actuatedsequentially.
 14. The method of claim 13, wherein said first and secondneedles are deployed sequentially.
 15. The method of claim 5, furthercomprising: actuating said first and second arms from said secondposition to said first position; and withdrawing said distal end of saidelongate body from said patent foramen ovale.